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 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's complete address was not provided.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition that the adapter device was cracked on the crossbar was confirmed.An assessment was performed on the device which found that the t-handle was broken.It was determined that the device was most likely side loaded when used with the impactor which is improper device use.The assignable root cause was determined to be due to user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.(b)(4).

Event Description

It was reported that during an unspecified surgical procedure it was observed that the adapter device broke in half near the "t" crossbar.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.During in-house engineering evaluation it was observed that the t-handle on the device was cracked on the crossbar and broken.This event did not occur during surgery.There was no patient involvement.All available information has been disclosed.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
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8890055
• MDR Text Key: 154556252
• Report Number: 1045834-2019-54287
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006099
• UDI-Public: 850915006099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 06/18/2019
• Date Manufacturer Received: 08/08/2019
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1