MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-02 for PIP SZ. 30 PROXIMAL PIP-200-30P-WW manufactured by Ascension Orthopedics.
[37738004]
It was reported the device broke during a procedure. The surgeon is very experienced with the device. The device broke during impaction. It was reported no patient injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[39854955]
Additional information received on february 12th 2016: the sales representative assumes the procedure was finished with the pip implant. The event maybe led to a very slight increase in surgery time (they would have to open another packet)? No more than 5 minutes. No consequences for the patient. The sales representative did not know the age or gender of the patient. The sales representative did not know which finger the implant was implanted. No pictures are available. Comments from the sales representative: "normally what happens is that the implant is placed in the bone cavity that has been prepared with the correct size broach. The implant is then place at the entrance to the cavity and using the correct impactor is impacted fully into the cavity. If the bone cuts (prior to broaching) have not been done correctly then the implant can break? I am sure this is what would have happened here. The device would definitely have been in contact with the patient. "
Patient Sequence No: 1, Text Type: N, H10
[43025330]
Integra has completed their internal investigation on 29mar2016. The additional investigation activities included: methods: review of device history records. Review of complaint history. Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. A review of complaints conducted in (b)(6) 2016 for pip implant fractures (both intra-op and post-op) during the previous 5 years showed (b)(4) complaints, not including this one. During this period of time there have been approximately (b)(4) units sold. The resulting overall rate of complaints is (b)(4)% ((b)(4)). A trend analysis of the yearly complaints conducted in (b)(6) 2016, showed it does not represent an adverse trend. Conclusion: the cause of the failure has been identified by the sales representative as resulting from improper bone cuts prior to broaching. However, other possibilities include 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, or off-angle loading.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2016-00010 |
| MDR Report Key | 5404766 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2015-01-26 |
| Date Added to Maude | 2016-02-02 |
| 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 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. 30 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2016-02-02 |
| Catalog Number | PIP-200-30P-WW |
| Lot Number | 150261T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-02 |