RESTORATION(TM) ADM. PRESS
Report
- Report Number
- 0002249697-2016-02157
- Event Type
- Malfunction
- Date Received
- July 1, 2016
- Date of Event
- June 6, 2016
- Report Date
- January 18, 2017
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K153345
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
AN EVENT REGARDING A FRACTURE INVOLVING AN ADM PRESS WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: . VISUAL INSPECTION WAS CARRIED OUT AS PART OF THE MATERIAL ANALYSIS REPORT, IT STATED "THE PARTS WERE EXAMINED WITH THE AID OF A STEREO MICROSCOPE AT MAGNIFICATIONS UP TO 50X. THE WELD BROKE THROUGH THE CENTER LINE OF THE FILLET WELD THAT WAS DEPOSITED BETWEEN THE LOWER ARM AND THE VERTICAL ARM.". LISI MEDICAL ORTHOPAEDICS (LMO), CONDUCTED AN INVESTIGATION ON THE RETURNED DEVICE. THIS REVIEW FOUND: "THE INVESTIGATION CONCLUDED THAT A FILLET WELD WAS USED TO JOIN THE LOWER ARM WITH THE VERTICAL ARM AND SUBSEQUENTLY BROKE THROUGH FATIGUE IN USE. THE FILLER METAL OF THE FILLET WELD AND THE LOWER ARM BOTH INDICATED THROUGH EDS THAT THE ALLOY USED IN BOTH CASES WAS CONSISTENT WITH A 431 STAINLESS STEEL ALLOY. NO FURTHER ANALYSIS COULD BE PERFORMED ON THE WELD FRACTURE AS NO INFORMATION WAS AVAILABLE PROVIDING THE WELD REQUIREMENT DETAILS. THE HOLE OF THE LOWER ARM AND THE POST OF THE UPPER ARM ARE DIMENSIONALLY COMPLIANT. THIS COMPLAINT WAS PRESENTED TO THE INSTRUMENT CELL AND THEY CONFIRMED THAT THERE IS NO MANUFACTURING ISSUE. ON THE DRAWING E-649-2, NO SPECIFIC WELDING REQUIREMENTS ARE MENTIONED ON THE DRAWING. AS AN IMPROVEMENT ACTION, IN NOVEMBER 2013 A TECHNICAL DOCUMENT WAS CREATED UNDER THE TEMPLATE L00001-12 (TITLE IS PARAMETERS FORM) TO DOCUMENT AND FORMALIZE THE WELDING PARAMETERS USED TO MANUFACTURE THE ADM PRESS, REFERENCE 1235-0-008". -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT REQUIRED AS THERE WAS NO ASSOCIATED PROCEDURE OR PATIENT INVOLVEMENT -DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: IN BOTH THE MAR AND THE SUPPLIER INVESTIGATION NO DEVICE NON-CONFORMANCES WAS DETECTED BUT AS A IMPROVEMENT ACTION A TECHNICAL DOCUMENT WAS CREATED BY THE SUPPLIER TO FORMALIZE THE WELDING PARAMETERS USED TO MANUFACTURE THE ADM PRESS, THE DEVICE UNDER THE SCOPE OF THIS INVESTIGATION WAS MANUFACTURED IN 2011, PRIOR TO THIS TECHNICAL DOCUMENT BEING CREATED NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
WHILE SETTING UP THE CASE AT THE HOSPITAL THE SURGICAL TECH NOTICED THE WELD WHERE THE HEAD SUPPORTING PIECE SITS WAS CRACKED, THE SET CAME FROM NATIONAL LOANERS WEST. THE SURGICAL TECH PUT A TRIAL IN TO SEE IF IT WOULD WORK AND THE WELD BROKE COMPLETELY. WE HAD AN EXTRA PRESS AND MOVED FORWARD WITH THE CASE.
WHILE SETTING UP THE CASE AT THE HOSPITAL THE SURGICAL TECH NOTICED THE WELD WHERE THE HEAD SUPPORTING PIECE SITS WAS CRACKED, THE SET CAME FROM NATIONAL LOANERS WEST. THE SURGICAL TECH PUT A TRIAL IN TO SEE IF IT WOULD WORK AND THE WELD BROKE COMPLETELY. WE HAD AN EXTRA PRESS AND MOVED FORWARD WITH THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419173 | RESTORATION(TM) ADM. PRESS | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | G3190232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |