MAUDE Adverse Event Report: SYNTHES OBERDORF SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.224

Device Problems Partial Blockage (1065); Material Discolored (1170); Overheating of Device (1437); Sticking (1597); Device Inoperable (1663); Incorrect Or Inadequate Test Results (2456); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that the sagittal saw attachment device was stuck; and that it was not working.During service and evaluation, it was observed that the sagittal saw attachment device bearing did not function and the device was blocked.It was further determined that the device failed the following pre-tests: check of free movement, check the oscillation frequency and check the saw performance.During troubleshooting, it was identified that the needle bearing was fixed but black discoloration was found on the shaft due to overheating.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6088957
• MDR Text Key: 59722338
• Report Number: 8030965-2016-15503
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1