MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE CUP-ADAPTER-PINNACLE STRAIGHT; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 1011-01-101

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reporter¿s complete facility address was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the t-handle of the kincise cup-adapter-pinnacle device was broken.It was reported that there were no delays to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device evaluation: the actual device was returned for evaluation.A visual and functional assessment was performed on the device which determined that the t-handle was cracked (almost broken in two pieces).It was further determined that the device was most likely side loaded when used with the impactor device, which was not what the device was designed for (user error), or it had been dropped.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE CUP-ADAPTER-PINNACLE STRAIGHT
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9497420
• MDR Text Key: 179547857
• Report Number: 1045834-2019-55153
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1