MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	656316
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "incident that has occurred on 5 occasions in the traumatological hospital corresponding to the surgeries that we have tendered with the radio distal variax plate the specific problem is that when the screw 2.7 is placed in the oval hole of the plate, it rolls, does not tighten, it becomes loose, although the length of the screw has been changed several times.The screw box was reviewed by checking the screw head, changing the screwdriver, talking and observing with the assistants and doctors about the technique used".
Event or Problem Description
As reported: "incident that has occurred on 5 occasions in the traumatological hospital corresponding to the surgeries that we have tendered with the radio distal variax plate the specific problem is that when the screw 2.7 is placed in the oval hole of the plate, it rolls, does not tighten, it becomes loose, although the length of the screw has been changed several times.The screw box was reviewed by checking the screw head, changing the screwdriver, talking and observing with the assistants and doctors about the technique used".
Additional Manufacturer Narrative
D4 lot number has been corrected.The reported event could be confirmed, since the locking thread of the screw is in the received condition.The device inspection revealed the following: the visual inspection has shown that the thread of the locking head is strongly damaged, the thread flanks are totally flattened from an excessive contact with the plate hole.The thread at the shaft is in a good condition with no visible damages.There are deformations in clockwise directions visible at the t8 recess, which indicates that the screw was exposed to high forces during insertion.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadvertently using a locking screw in the oblong hole of a distal radius locking plate.In this relation the operative technique (variax 2 system vax-st-62_rev.3, 03 - 2021) can be pointed out: "[the circular holes in the plates provide an option for locking and non¿locking.Oblong holes and compression holes provide an option for non-locking screws except in the variax foot system, variax 2 foot system, and the variax 2 mini fragment system which also features locking compression holes.In order to distinguish a locking screw from a non-locking screw, the top of the locking screw heads are laser marked with a black circular ring and inner dot as shown here.] [original statement] if more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11926341
• Report Number: 0008031020-2021-00251
• Device Sequence Number: 16918699
• Product Code: HWC
• UDI-Device Identifier: 07613327068689
• UDI-Public: 07613327068689
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 656316
• Device Catalogue Number: 656316
• Device Lot Number: 1000296696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1