MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for PIP BROACH, MIDDLE, SIZE 30 SILICONE PIP 170863 manufactured by Stryker Gmbh.
[140144857]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[140144858]
The following event was reported: "during pip silicone ancillary use: small metal debris were observed when using proximal and distal raps". We observed metal debris as soon as the proximal rasps 30 and 40 and the distal rasps 20 and 30 were impinged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-00323 |
| MDR Report Key | 8453846 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2015-09-19 |
| Date Added to Maude | 2019-03-26 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIP BROACH, MIDDLE, SIZE 30 SILICONE PIP |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, POLYMER |
| Product Code | KYJ |
| Date Received | 2019-03-26 |
| Catalog Number | 170863 |
| Lot Number | 15234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-26 |