FDA Adverse Event
Malfunction
Summary report: N
HP MBT CEM KEEL PUNCH SZ 4-7
MDR report key: 4091225
·
Received September 16, 2014
Report
- Report Number
- 1818910-2014-28114
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED BREAKAGE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURE; HOWEVER, HEAVY USAGE OVER TIME AND OR USER ERROR/MISUSE COULD BE CONTRIBUTING FACTORS. CPAP (B)(4) HAS BEEN INITIATED TO INVESTIGATE, IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE INSTRUMENT BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573406 | HP MBT CEM KEEL PUNCH SZ 4-7 | KNEE INSTRUMENT/TRIAL | LXH | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC | J0609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |