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 2016-08-29 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[53359110]
It was reported the device fractured upon implantation. The patient was undergoing an arthroplasty procedure for two fingers. The first finger procedure went beautifully. During the second finger implantation the pyrocarbon fractured during the tap. The final tap snapped the head of the implant off and left the stem in the bone. The surgeon reamed the remaining stem out successfully using a k-wire. He completed the procedure by inserting another implant (final implant available - the sales rep only had 3 of this size). The final implant did not position perfectly. The surgeon did broach again. The trail implant placed well. There might have been extra space in the canal. The final implant was rotated slightly. This outcome might be due to the breaking of the implant and removing the stem that happened initially. The surgeon feels the patient will be happy with the outcome of the procedure. He did mention that when the physician's assistant was tapping the pyrocarbon implant, he might have tapped it the wrong way.
Patient Sequence No: 1, Text Type: D, B5
[57950545]
Integra has completed their internal investigation on 28sep2016. The investigation activities included: methods: -evaluation of actual device. -review of device history records. - review of complaint management database for similar complaints. Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. (b)(4), this is considered an adverse trend. Conclusion: the cause of the failure has been previously identified as resulting from impacting the unsupported head when the stem of the implant has not been fully inserted into the medullary canal due to an improperly prepared oblique osteotomy. The complaint report identifies the possible root cause as a result of the tapping technique utilized by the physician? S assistant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2016-00034 |
| MDR Report Key | 5910452 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2016-09-28 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2016-08-29 |
| 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 | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| 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 | 2016-08-29 |
| Returned To Mfg | 2016-08-25 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 153957T |
| 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 | 1. Required No Informationntervention | 2016-08-29 |