MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC RECIPROCATING SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED

Catalog Number 05.001.225

Device Problems Device Inoperable (1663); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter¿s phone number: (b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the reciprocating saw attachment device was blocked. There were no delays in the surgical procedure. It was not reported if a spare device was available for use. There was patient involvement. There were no 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

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the gear was seized, jammed and heavy moving. It was also determined that the device failed pre-test for check the saw performance, check the oscillation frequency and check of free movement. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: RECIPROCATING SAW ATTACHMENT FOR TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7327916
• MDR Text Key: 102026187
• Report Number: 8030965-2018-51902
• Device Sequence Number: 1
• Product Code: HWE
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 05.001.225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No