MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT; PLATE, FIXATION, BONE

Model Number	628526S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Injury (2348)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported, that on may 22.Hook plate 6 hole / 16mm / left was used.After two and a half months, patient felt a little pain.After 4 months, erosion of subacromial happened because of hook, variax clavicle hook was explanted.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More information such as x-rays, patient post-operative activity level, ¿ are needed to be able to determine a definitive root cause.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
It was reported, that on (b)(6).Hook plate (b)(4) hole / 16mm / left was used.After two and a half months, patient felt a little pain.After (b)(4) months, erosion of subacromial happened because of hook, variax clavicle hook was explanted.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9513700
• Report Number: 0008031020-2019-02355
• Device Sequence Number: 2080036
• Product Code: HRS
• UDI-Device Identifier: 07613327085549
• UDI-Public: 07613327085549
• Combination Product (Y/N): N
• 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): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: 628526S
• Device Catalogue Number: 628526S
• Device Lot Number: Y01851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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: Required Intervention
• Patient Age: 68 YR