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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC RECIPROCATING SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED Back to Search Results
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.
 
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Brand NameRECIPROCATING SAW ATTACHMENT FOR TRS
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7327916
MDR Text Key102026187
Report Number8030965-2018-51902
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

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