MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-09-10 for RECLAIM PROXIMAL REAMER 20MM 297520105 manufactured by Depuy Ireland - 9616671.
[119653848]
(b)(4). Investigation summary ==> examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Additional narrative: 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
[119653849]
Customer reports that they received a second entire hip set with rust on almost every part of the kit on (b)(6) (this 2nd kit was sent to replace the first one sent on and received on (b)(6) (see (b)(4)). This kit went to customer on october 11th, 2017 and was new at the time (1st use), it came back to (b)(4) and was checked on october 19th 2017. Then it goes to customer on (b)(6) this year. Impacted products will be filled in when we will received the kit back on (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[122112115]
Product complaint # (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Device history lot: null. Device history batch: null. Device history review: null. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-68752 |
| MDR Report Key | 7859482 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-09-10 |
| Date of Report | 2018-08-14 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2012-07-24 |
| Date Added to Maude | 2018-09-10 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| 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 | RECLAIM PROXIMAL REAMER 20MM |
| Generic Name | RECLAIM INSTRUMENTS : REAMERS |
| Product Code | HTR |
| Date Received | 2018-09-10 |
| Returned To Mfg | 2018-01-18 |
| Catalog Number | 297520105 |
| Lot Number | SO2004519 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK, MUNSTER EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-10 |