MAUDE Adverse Event Report: STRYKER GMBH DISTAL POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR RIGHT HUMERUS 4 HOLE / L105; PLATE, FIXATION, BONE

Catalog Number	629264S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
As reported: "when the plate was bent, it broke.Even though it was not bent too much.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the risk management file review, possible cause of failure could be user related issue (reverse bending during plate shaping) if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "when the plate was bent, it broke.Even though it was not bent too much.".

• Brand Name: DISTAL POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR RIGHT HUMERUS 4 HOLE / L105
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10586299
• Report Number: 0008031020-2020-02270
• Device Sequence Number: 3143941
• Product Code: HRS
• UDI-Device Identifier: 04546540597762
• UDI-Public: 04546540597762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 06/30/2022
• Device Catalogue Number: 629264S
• Device Lot Number: L29377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1