MAUDE Adverse Event Report: SYNTHES GMBH KINCISE PINNACLE SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1011-01-101

Device Problems Material Fragmentation (1261); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch 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 threaded portion of the cup/liner impactor device was chipped, and the parts would not thread on properly.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.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 report 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and determined that the thread was damaged, which was consistent with improper handling (user error).It was determined that the device was unable to be assembled.It was further determined that the device failed pretest for visual assessment, threaded fitting assessment and threaded fitting assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.

• Brand Name: KINCISE PINNACLE SHELL/LINER IMPACTOR
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11064410
• MDR Text Key: 223618749
• Report Number: 1045834-2020-02157
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 12/22/2020
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1