MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-06 for HP MBT CEM KEEL PUNCH SZ 4-7 9505-02-012 950502012 manufactured by Depuy Orthopaedics Inc Us.
[184546686]
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: examination of the returned device confirmed the two tabs were slightly bent/deformed. The investigation did not establish that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[184546687]
The teeth at the junction of the handle attachment where observed to be bent before surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07093 |
| MDR Report Key | 9800240 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-06 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2009-11-15 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HP MBT CEM KEEL PUNCH SZ 4-7 |
| Generic Name | KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET |
| Product Code | LRY |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 9505-02-012 |
| Catalog Number | 950502012 |
| Lot Number | J1109 |
| 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 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |