MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE CUP-ADAPTER-PINNACLE STRAIGHT; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1011-01-101

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

(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 an unspecified surgical procedure it was observed that the adapter device was broken by the t-handle and was almost in two pieces.It was not reported if there was a delay in the procedure due to the event.It was not reported if a spare device was available for use.There was patient involvement reported.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.It was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (june 18, 2018) has been updated to reflect the date the device was manufactured.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the adapter device visibly had a broken t-handle, and the pinnacle adapter was non-functional.It was determined that the unit most likely was used slide load with the impactor which is not what the unit was designed for.The assignable root cause of this condition was determined to be due to user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: KINCISE CUP-ADAPTER-PINNACLE STRAIGHT
• 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: 8649542
• MDR Text Key: 146358360
• Report Number: 1045834-2019-53691
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• 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: 05/31/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1