MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL

Catalog Number PIP-200-30P-WW

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The perforator was not returned for evaluation, therefore, an evaluation of the device could not be performed.Lot number information has been provided, therefore, manufacturing records were reviewed, and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be re-opened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

A facility reported the pip proximal implant broke when it was being inserted into the patient.All broken parts were retrieved, and the event led to 45 minutes surgical delay with no patient injury.The procedure was completed with a replacement device.

Manufacturer Narrative

Complaint sample was returned for evaluation: dhr: a review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.Failure analysis: visual examination of the part found that the head was broken from the stem of the implant.The failure was confirmed.Root cause: visual examination of the part determined that the potential causes identified for similar intraoperative pip fractures (improperly prepared oblique osteotomy, improper placement of the implant (e.G., impacting unsupported head with too much force), or improper implant size selection) likely contributed to this incident.

Event Description

N/a.

• Brand Name: PIP SZ. 30 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 11047246
• MDR Text Key: 223455384
• Report Number: 1651501-2020-00024
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: PIP-200-30P-WW
• Device Lot Number: 185169T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1