FDA Adverse Event
Malfunction
Summary report: N
HP MBT CEM KEEL PUNCH SZ 4-7
MDR report key: 4089931
·
Received September 15, 2014
Report
- Report Number
- 1818910-2014-27943
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- June 11, 2013
- Report Date
- June 11, 2013
- Manufacturer
- 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: 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 HP MBT KEEL PUNCHES ARE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569852 | HP MBT CEM KEEL PUNCH SZ 4-7 | KNEE INSTRUMENT/TRIAL | LXH | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC | J1207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |