MAUDE Adverse Event Report: STRYKER GMBH OLECRANON PLATE VARIAX FOR RIGHT ULNA 6 HOLE / L113MM; PLATE, FIXATION, BONE

Model Number	629366
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
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 proximal ulna.It was reported that in inserting a vari-ax 2 core locking screw into the plate, the screw would not lock.The surgeon removed the screw and tried another.The second screw would not lock.A different plate was implanted and vari-ax (not vari-ax 2) locking screws were used.The screws locked into the plate.At the back table, the heads of the first 2 screws appeared to be compromised.A third vari-ax 2 locking screw was inspected and found to be free of defect.When inserting the screw into the plate, it would not lock.The screw was removed and the head appeared to be compromised.A vari-ax screw was then inserted in the same hole as the first screws and it locked with no issue.Rep reported a surgical delay of approximately 30-40 minutes.Rep reported via phone that the third screw was discarded.
Event or Problem Description
Primary procedure, right proximal ulna.It was reported that in inserting a vari-ax 2 core locking screw into the plate, the screw would not lock.The surgeon removed the screw and tried another.The second screw would not lock.A different plate was implanted and vari-ax (not vari-ax 2) locking screws were used.The screws locked into the plate.At the back table, the heads of the first 2 screws appeared to be compromised.A third vari-ax 2 locking screw was inspected and found to be free of defect.When inserting the screw into the plate, it would not lock.The screw was removed and the head appeared to be compromised.A vari-ax screw was then inserted in the same hole as the first screws and it locked with no issue.Rep reported a surgical delay of approximately 30-40 minutes.Rep reported via phone that the third screw was discarded.
Additional Manufacturer Narrative
The reported event that olecranon plate variax for right ulna 6 hole / l113mm was alleged of 'no locking effect' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate screw angulation durin screw insertion.The device inspection revealed the following: two locking screws and one olecranon plate were received all badly damaged.The two front holes of the plate are clearly damaged to such an extend that the locking grooves are not functional anymore, therefore it is not possible to lock even a new screw.Also the threaded parts of both locking heads are badly damaged.Again tests showed that neither screw was still functional.We can only suppose that the surgeon may have encountered some complications during screw insertion (wrong angle), which made him decide to use a new plate and screws to complete the operation.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 any further information is provided, the investigation report will be updated.

• Brand Name: OLECRANON PLATE VARIAX FOR RIGHT ULNA 6 HOLE / L113MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7531506
• Report Number: 0008031020-2018-00370
• Device Sequence Number: 1775068
• Product Code: HRS
• UDI-Device Identifier: 07613154970759
• UDI-Public: (01)07613154970759
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101056
• 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): 08/10/2018

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 Model Number: 629366
• Device Catalogue Number: 629366
• Device Lot Number: L55450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 71 YR