MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 2.7MM / L18MM; PLATE, FIXATION, BONE

Catalog Number	614518
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that locking screw variax full thread 2.7mm / l18mm was alleged of 'poor fixation' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by using the wrong type of screws for the plate selected.Indeed, after inspection, it was found that t10 screws were used distally instead of t8 screws, which explains why they could not be locked into the plate.The head of the t10 screws is bigger than the one of t8.The device inspection revealed the following: it can be noticed based on the deformation of the material of the smartlocking mechanism of the plate that a screw was installed in every circular hole of the plate.This is further confirmed by the x-rays provided.However, none of the oblong holes was filled by a screw.The screws that were returned were tested with the plate.The proximal screws are 3.5, t10 screws which lock perfectly with the plate.The distal screws however, do not lock into the plate at all.These particular screws are variax 1, 2.7 mm screws but the heads are valid for a t10 screwdriver, and this explains the reason they could not be locked.This mistake could have been avoided more easily if variax 2 screws were used, since they are color coded, and thus more easily identified.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 or Problem Description
Two weeks after an arthrodesis on the wrist, it was found that the used screws were not held in the variax plate.The surgeon reports that he already had the feeling during screwing that the locking mechanism does not work properly.The device was removed and will return for evaluation.
Additional Manufacturer Narrative
The reported event that locking screw variax full thread 2.7mm / l18mm was alleged of 'poor fixation' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by using the wrong type of screws for the plate selected.Indeed, after inspection, it was found that t10 screws were used distally instead of t8 screws, which explains why they could not be locked into the plate.The head of the t10 screws is bigger than the one of t8.The device inspection revealed the following: it can be noticed based on the deformation of the material of the smartlocking mechanism of the plate that a screw was installed in every circular hole of the plate.This is further confirmed by the x-rays provided.However, none of the oblong holes was filled by a screw.The screws that were returned were tested with the plate.The proximal screws are 3.5, t10 screws which lock perfectly with the plate.The distal screws however, do not lock into the plate at all.These particular screws are variax 1, 2.7 mm screws but the heads are valid for a t10 screwdriver, and this explains the reason they could not be locked.This mistake could have been avoided more easily if variax 2 screws were used, since they are color coded, and thus more easily identified.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 or Problem Description
Two weeks after an arthrodesis on the wrist, it was found that the used screws were not held in the variax plate.The surgeon reports that he already had the feeling during screwing that the locking mechanism does not work properly.The device was removed and will return for evaluation.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 2.7MM / L18MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8256793
• Report Number: 0008031020-2019-00029
• Device Sequence Number: 19311672
• Product Code: HRS
• UDI-Device Identifier: 07613154969517
• UDI-Public: 07613154969517
• Combination Product (Y/N): N
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 614518
• Device Lot Number: J41449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/08/2019
• 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: Required Intervention
• Patient Age: 78 YR