MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 3 HOLE / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628223S
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device discarded by hospital.
Event or Problem Description
It was reported that the 4th locking screw would not lock on the superior lateral plate variax clavicle 3 hole plate after locking 3 screws distally.The surgeon tried several times but the screw would not lock.The screw was not inserted.
Additional Manufacturer Narrative
The reported event that superior lateral plate variax clavicle 3 hole / right was alleged of 'no locking effect' could not be confirmed, since the device was not returned (implanted) for evaluation and no other evidences were provided.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.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 the 4th locking screw would not lock on the superior lateral plate variax clavicle 3 hole plate after locking 3 screws distally.The surgeon tried several times but the screw would not lock.The screw was not inserted.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 3 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6972839
• Report Number: 0008031020-2017-00627
• Device Sequence Number: 13767073
• Product Code: HRS
• UDI-Device Identifier: 04546540687104
• UDI-Public: 04546540687104
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• 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): 01/29/2018

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 628223S
• Device Lot Number: L24311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: Other