MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-22 for DURALOC STR CUP IMPACTOR 236071000 manufactured by Depuy Orthopaedics Inc Us.
[145784948]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[145784949]
It was reported that the impaction end of the duraloc cup impactor that the surgeon was using to insert the pinnacle acetabular shell in this patient's hip replacement case had a mashed edge, most likely from being struck off angle by a mallet, which created a metal splinter on the edge of the rim of the impactor. The surgeon cut his finger slightly on the metal splinter (jagged edge) during the case, which required him to administer first aid to his finger and then rescrub for the case. The incident only delayed the case for a few minutes, since he had a joint replacement fellow assisting him with the case. Surgical delay 2 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-94307 |
| MDR Report Key | 8632345 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2006-07-15 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURALOC STR CUP IMPACTOR |
| Generic Name | HIP INSTRUMENTS : IMPACTORS |
| Product Code | HWA |
| Date Received | 2019-05-22 |
| Returned To Mfg | 2019-05-16 |
| Catalog Number | 236071000 |
| Lot Number | AG0796 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |