MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 0

Catalog Number SPIP-520-0-WW

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.As such, a failure analysis could not be conducted.A review of the lot records was conducted, and did not find any indication of problems that could have caused or contributed to the complaint.As the implant was not returned for investigation, a possible root cause could not be found.The reported complaint was not confirmed.

Event Description

A distributor reported that the customer was unhappy about the lack of backup sizes for an spip-520-0-ww silicone pip in a case they had done.On (b)(6) 2018, the patient came in for hand surgery due to joint arthritis: right long finger pip joint and right ring pip joint arthroplasty.During surgery, the surgeon decided to put in a size #0 for one finger, and then needed the same size on a second finger.The implant bank that was shipped to the facility only contained one size #0.The surgeon decided not to use a different size and instead closed the patient and would revisit to do the other finger.Now the patient will need to go through another surgery and post op therapy.There was never a plan to have to come back for further procedures on this patient.

• Brand Name: SILICONE PIP SZ. 0
• Type of Device: SILICONE PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8735521
• MDR Text Key: 149223266
• Report Number: 1651501-2019-00022
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K082231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-0-WW
• Device Lot Number: 174078T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1