MAUDE Adverse Event Report: STRYKER GMBH ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE; PLATE, FIXATION, BONE

Catalog Number	628310S
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that anterior midshaft plate variax clavicle 10 hole 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 too much mechanical force which was applied during plate bending.Note; the surgeon completed the case using the broken plate (in conjunction with a hook plate) as this appeared to be adequate for the patient.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that during a variax case as he went to bend the 10 hole variax clavicle plate a piece snapped off the end while using the bender.The surgeon completed the case using the broken plate (in conjunction with a hook plate) as this appeared to be adequate for the patient.

• Brand Name: ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8171044
• Report Number: 0008031020-2018-01070
• Device Sequence Number: 16577982
• Product Code: HRS
• UDI-Device Identifier: 04546540687180
• UDI-Public: 04546540687180
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 628310S
• Device Lot Number: V31224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/17/2018
• 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