MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number 628007S

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

It was reported: after fracture the patient was treated with a clavicle plate on (b)(6) 2020 , which had to be replaced on (b)(6) 2020 because a screw had loosened.Information regarding the responsible hospital/customer is not available at the moment.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned and no other evidences like a medical report was available.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information, the affected device as well as the medical records must be available in this case to determine the exact root cause of the failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported: after fracture the patient was treated with a clavicle plate on(b)(6) 2020 , which had to be replaced on (b)(6) 2020 because a screw had loosened.Information regarding the responsible hospital/customer is not available at the moment.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10237057
• MDR Text Key: 199936481
• Report Number: 0008031020-2020-01844
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K113760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 628007S
• Device Lot Number: Y22182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention