MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE REPL CAP HEAD ADAPTER FEMORAL; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1013-00-901

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 sterile processing it was observed that the adapter device was cross threaded by a sterile processing agent.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.The date of manufacture (dom) was documented as unknown in the initial medwatch report.The dom has been corrected to june 14, 2019.The udi has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.It was documented in the initial medwatch report that the serial number was unknown.The serial number (b)(4) has been updated.The unique identifier (udi) has been updated accordingly.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the adapter device and observed that the threads were cross threaded causing thread damage.Therefore, the reported condition was confirmed.It was determined that the damage threads caused by cross threading the device was due user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).

• Brand Name: KINCISE REPL CAP HEAD ADAPTER FEMORAL
• 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: 8715821
• MDR Text Key: 148543230
• Report Number: 1045834-2019-53853
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006143
• UDI-Public: 850915006143
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013-00-901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1