MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE PINNACLE SHELL/LINER IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1011-01-101

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi (b)(4).

Event Description

It was reported that the male end of the cup impactor device handle sheared off at the coupling.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the male end of the cup impactor handle sheared off at the coupling was confirmed.An assessment was performed on the cup-adapter t-handle and found the proximal end of the cloverleaf broke off from the t-handle, consistent with having been dropping or other radial (off-axis) force, which is improper handling.It was further determined that the device failed pretest for visual assessment.The assignable root cause of this condition was determined to be traced to user, which is user error.

• Brand Name: KINCISE PINNACLE SHELL/LINER IMPACTOR
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10854409
• MDR Text Key: 222540215
• Report Number: 1045834-2020-01905
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006099
• UDI-Public: 850915006099
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 11/17/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1