MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK 3-D PLATTE,3X2HOLES; PLATE, FIXATION, BONE

Catalog Number	57-15391
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during the operation, the plate broke and did not cause any harm to the patient.During the operation, the doctor replaced the plate to complete the operation.There was no surgical delay, and no adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate mechanical force which had been applied during pre-bending.The device inspection revealed the following: the returned plate is indeed damaged / broken off as reported.It is clearly visible that the surgeon may have encountered some difficulties to correctly position the plate during bending and completely damaged / deformed the plate in several places.These damages / deformations clearly indicate though, that inadequate mechanical force had been applied during pre-bending.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.
Event or Problem Description
It was reported that during the operation, the plate broke and did not cause any harm to the patient.During the operation, the doctor replaced the plate to complete the operation.There was no surgical delay, and no adverse consequences were reported.

• Brand Name: 2.3 M VARIAX HAND LOCK 3-D PLATTE,3X2HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8453844
• Report Number: 0008031020-2019-00324
• Device Sequence Number: 429276
• Product Code: HRS
• UDI-Device Identifier: 07613154496754
• UDI-Public: 07613154496754
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 57-15391
• Device Lot Number: 1000174650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1