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

Catalog Number	628526S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: the patient's bone quality was fragile.And the plate was dislodged from the bone along with the screws.Revision surgery is planed on (b)(6) 2024.
Additional Manufacturer Narrative
Based on the available information, the device will not be returned.Therefore, an evaluation of the device cannot be performed.A review of the device history is not possible, because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text: device owned by the patient.
Additional Manufacturer Narrative
Please note corrections to section h6 (method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the patient's bone quality was fragile and the plate was dislodged from the bone along with the screws.Revision surgery is planed on (b)(6) 2024.".

• 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 ; 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: 18738940
• Report Number: 0008031020-2024-00108
• Device Sequence Number: 12570016
• Product Code: HRS
• UDI-Device Identifier: 07613327085549
• UDI-Public: 07613327085549
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 628526S
• Device Lot Number: AA2089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown