MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L60MM; PLATE, FIXATION, BONE

Model Number 657360

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

Manufacturer Narrative

The reported event that locking screw variax2 t10, full thread, 3.5mm / l60mm 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.

Event 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.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L60MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7531490
• MDR Text Key: 108995835
• Report Number: 0008031020-2018-00371
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327087437
• UDI-Public: (01)07613327087437
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657360
• Device Catalogue Number: 657360
• Device Lot Number: L38322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR