MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 6 HOLE / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628026
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Primary procedure, right clavicle.It was reported that in implanting the variax2 core 3.5 locking screws into the clavicular plate, the screws would not lock - they kept spinning when they should have locked.Rep obtained locking screws from a variax 1 ankle solution set, which locked as expected.The plate is implanted and the reported screws are available for return.Rep reported that surgeon was following the surgical technique throughout the procedure.There was a surgical delay of 5 minutes.
Event or Problem Description
Primary procedure, right clavicle.It was reported that in implanting the variax2 core 3.5 locking screws into the clavicular plate, the screws would not lock - they kept spinning when they should have locked.Rep obtained locking screws from a variax 1 ankle solution set, which locked as expected.The plate is implanted and the reported screws are available for return.Rep reported that surgeon was following the surgical technique throughout the procedure.There was a surgical delay of 5 minutes.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 6 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7891404
• Report Number: 0008031020-2018-00613
• Device Sequence Number: 1682080
• Product Code: HRS
• UDI-Device Identifier: 07613252441922
• UDI-Public: 07613252441922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 11/12/2018

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 Catalogue Number: 628026
• Device Lot Number: Y03508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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
• Patient Age: 14 YR