MAUDE Adverse Event Report: STRYKER GMBH DISTAL POSTERIOR MEDIAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 3 HOLE / L80MM; PLATE, FIXATION, BONE

Catalog Number	629303S
Medical Device Problem Codes	Positioning Failure (1158); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
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
As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or 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 force during screw insertion.The device inspection revealed the following: note that the two mentioned screws were not returned for investigation.Tests using sample screws have shown that 2.7mm as well as 3.5mm screws could be inserted and locked accordingly, despite visible traces from previously inserted locking screws.Except into one screw hole as this particular hole was indeed badly damaged.A close up of the back view of the baldly damaged screw hole clearly revealed that almost the entire material of the locking notch has been torqued off during screw insertion.This clearly indicates that far too much mechanical force had been applied during screw insertion / final tightening.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
As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or adverse consequences were reported.

• Brand Name: DISTAL POSTERIOR MEDIAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 3 HOLE / L80MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9099649
• Report Number: 0008031020-2019-01295
• Device Sequence Number: 16741233
• Product Code: HRS
• UDI-Device Identifier: 07613327082920
• UDI-Public: 07613327082920
• Combination Product (Y/N): N
• PMA/510(K) Number: K141677
• 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,Followup
• Report Date (Section B): 12/23/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 629303S
• Device Lot Number: V18639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1