FDA Adverse Event
Malfunction
Summary report: N
LINXHT CALIBRATED PASSER PIN, 2.4MM
MDR report key: 1693715
·
Received May 10, 2010
Report
- Report Number
- 1221934-2010-00183
- Event Type
- Malfunction
- Date Received
- May 10, 2010
- Date of Event
- April 27, 2010
- Report Date
- April 27, 2010
- Manufacturer
- DEPUY MITEK
- Product Code
- NBH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, THE TIPS OF 4 PASSER PINS BROKE OFF INTO THE BONE. ALL OF THE FRAGMENTS WERE RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. COMPLAINT DEVICES DISCARDED BY USER FACILITY. ALSO SEE ASSOCIATED MDRS 1221934-2010-00184, 1221934-2010-00185 AND 1221934-2010-00186.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINXHT CALIBRATED PASSER PIN, 2.4MM | ARTHROSCOPIC INSTRUMENT | NBH | DEPUY MITEK | 254728 | 0907529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |