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

Model Number 628526S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Injury (2348)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9513700
• MDR Text Key: 182606360
• Report Number: 0008031020-2019-02355
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327085549
• UDI-Public: 07613327085549
• Combination Product (y/n): N
• PMA/PMN Number: K140259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR