MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-22 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[142669983]
The device was not returned for evaluation, so the failure mode could not be confirmed. A review of the lot records was conducted, and did not discover any indications of problems that could have caused or contributed to the complaint. The reported complaint was not confirmed. While the root cause is unknown for this case, similar issues that resulted in intra-operative pip fractures have been attributed to improperly prepared oblique osteotomy, improper placement of the implant (e. G. , impacting unsupported head with too much force), or improper implant size selection.
Patient Sequence No: 1, Text Type: N, H10
[142669984]
An account manager reported that on (b)(6) 2019, the pip-200-20p-ww pip sz. 20 proximal implant head broke off during impaction. The implant stem was stuck inside the bone canal and had to be removed by bending a pair of the hospitals forceps. Minimal debris was left in the surgical site and this was thoroughly checked by the surgeon, and they were able to complete the procedure with a replacement product available. The event lead to 10 minutes surgical delay with no consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00013 |
| MDR Report Key | 8537100 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-22 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIP SZ. 20 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2019-04-22 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 163401T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-22 |