MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 1

Catalog Number SPIP-520-1-WW

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Dhr - review of manufacturing records for (b)(4) lot 192715t showed no evidence of a nonconformance that may have caused or contributed to the reported event.The labels included in the dhr show size 1 reflected on the inner pouch, outer pouch, and box labels.The devices from the reported incident have not been returned to date; however, the images provided by the customer confirm the event.Internally, product was quarantined, and the initial investigation conducted.Based on the information received to date, the mislabeling event occurred in-house at integra.Investigation for this event will continue.

Event Description

It was reported that a surgeon prepared a joint for a size 1 silicone pip implant during surgery on (b)(6) 2019.The first implant box was opened, and it was noticed that everything was labeled size 1 except for the sterile implant and package that was labeled size 0.Another size 1 implant was opened, and the same issue was observed.(both packages had the same lot number: 192715t.) the surgeon then had to prepare the joint for the next size up.No patient injury was reported; however, there was a delay in surgery (unknown for how long).

• Brand Name: SILICONE PIP SZ. 1
• 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: 8883860
• MDR Text Key: 200877142
• Report Number: 1651501-2019-00036
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-1-WW
• Device Lot Number: 192715T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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