FDA Adverse Event
Malfunction
Summary report: N
PENETRATING SUTURE GRASPER 35DEGREE
MDR report key: 1182701
·
Received September 25, 2008
Report
- Report Number
- 1221934-2008-00447
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 2, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- HRX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME, AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A FAILURE ANALYSIS. WHEN ALL IS SAID AND DONE, THE RESULTS AND CONCLUSIONS OF THE INVESTIGATION WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR AFFILIATE IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, A PORTION OF THE DISTAL END OF A MITEK PENETRATING SUTURE GRASPER BROKE OFF INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENETRATING SUTURE GRASPER 35DEGREE | ARTHROSCOPIC INSTRUMENT | HRX | DEPUY MITEK | 214601 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |