MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-03-13 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[102343752]
Integra has completed their internal investigation on march 9, 2018. It was reported that there was an issue with a pip. Additional information received that during an operation on (b)(6) 2018, the prostheses was being placed and ready to be pushed in the implant pip-200-20p-ww (173348t) when it crumbled. No force was used to enter the prostheses. Only a few pieces were able to be salvaged from the operation. The rest had crumbled so finely that the finger had to be rinsed in order to remove the residue. There was a ten minute increase in surgical duration; however, the patient was not injured, and there was no harm reported. The part has not been returned to date; therefore, no failure analysis is possible. The root cause of the reported event is unknown. In the past, 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
[102343753]
It was reported that the device broke during a procedure. The prostheses was being placed and ready to be pushed in the implant pip-200-20p-ww when it crumbled. No force was used to enter the prostheses. No force was used to place the implant. Only a few pieces were able to be salvaged from the operation. The rest had crumbled so finely that the finger had to be rinsed in order to remove the residue. No patient injury reported and the event lead to 10 minutes surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00019 |
| MDR Report Key | 7335017 |
| Report Source | FOREIGN |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2018-03-13 |
| 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 SONIA IRIZARRY |
| 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 | 2018-03-13 |
| Returned To Mfg | 2018-06-12 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 173348T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-13 |