MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 5 HOLE / 20MM / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628555S
Medical Device Problem Codes	Break (1069); Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the plate was broken during bending of the plate in this case of combination with another company's anchor for acromioclavicular joint dislocation." another plate was used to complete the surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows significant traces of intense usage as evidenced by scratches, dents, and nicks all over the surface.Both the pieces of the broken plate were returned for investigation and evidence of forced usage were found on them.The breakage pattern reveals that the neck region of the plate was under continuous loading and bending forces which resulted into the breakage of the plate into two parts.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.Based on the investigation, the root cause was attributed to a user related issue.The failure was caused by application of loading and bending forces which led to breakage.Also the fact that another companies device was used cannot be overlooked.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the plate was broken during bending of the plate in this case of combination with another company's anchor for acromioclavicular joint dislocation." another plate was used to complete the surgery.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 5 HOLE / 20MM / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17782663
• Report Number: 0008031020-2023-00343
• Device Sequence Number: 6551595
• Product Code: HRS
• UDI-Device Identifier: 07613327085488
• UDI-Public: 07613327085488
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140259
• 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): 11/23/2023

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: 628555S
• Device Lot Number: H66694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male