MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-02-18 for PIP, BROACH, PROXIMAL, SZ.10 BRH-200-10P manufactured by Ascension Orhtopedics.
[4359644]
It was reported during a pip implantation surgery on the left hand fourth finger, the rasp of a pip broach, size 10, broke. The surgeon got the broken piece out and successfully completed the procedure. On (b)(6) 2014 additional information was received. 'the surgeon clasped the broken piece and removed it via the entry hole; this took about 15 to 20 minutes. The surgeon used a small clasp/tweezers to enter the proximal phalangeal canal and gripped the broken piece. The surgeon got the broken piece out and successfully completed the procedure. Additional information was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[11875703]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00008 |
| MDR Report Key | 3770728 |
| Report Source | 01,07,08 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-27 |
| Date Mfgr Received | 2014-01-31 |
| Date Added to Maude | 2014-05-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIP, BROACH, PROXIMAL, SZ.10 |
| Generic Name | PIP INSTRUMENTS |
| Product Code | KWF |
| Date Received | 2014-02-18 |
| Catalog Number | BRH-200-10P |
| Lot Number | 8977-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORHTOPEDICS |
| Manufacturer Address | AUSTIN TX 78757 US 78757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-18 |