MAUDE Adverse Event Report: STRYKER GMBH BENDING PLIERS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702903
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
While in use, the metal split.
Event or Problem Description
While in use, the metal split.
Additional Manufacturer Narrative
The reported event that bending pliers was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by repeated powerful overload during the bending process over the years (manufactured in oct.2014).The device inspection revealed the following: the clamp of the returned plate bender, which is holding the long bending arm in place, is indeed cracked.Note that the device was manufactured in october 2014, this lead us believe that the breakage resulted due to repeated powerful overload during the bending process over the years in use.A review of the device history for the reported lot did not indicate any abnormalities.Nevertheless, note that a corrective action has been initiated in order to enhance / eliminate such occurrences in the future.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: BENDING PLIERS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8075199
• Report Number: 0008031020-2018-00981
• Device Sequence Number: 1516597
• Product Code: LXH
• UDI-Device Identifier: 04546540382078
• UDI-Public: 04546540382078
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702903
• Device Lot Number: F11924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other