MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW IMN SCREWS Ø5X42.5MM; SCREW, FIXATION, BONE

Model Number	2360-5042S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2022
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
As reported: "during the external apposition/compression procedure for t2 alpha tibia nail, the 42.5 mm locking screw that had been inserted into the proximal oval hole was bent.Screw removal was possible, but the operation time was prolonged by 30 minutes.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the locking screw is bent as complained.The device inspection revealed the following: the visual inspection has shown that there is a strong deformation in the middle of the threaded shaft visible.On the top side of the deformation is a very strong impression mark from the compression screw visible, while the thread flanks on the bottom side of the deformation are totally flattened from an excessive contact with the bottom of the oblong hole from the nail.These damages and the deformation of the screw indicate that during the procedure very high forces were applied for compression.The inspection has also shown that the hexagon recess is strongly damaged, most likely caused during the forcible removal of the deformed screw.The relevant dimensions were verified during the inspection and no deviation from the specification could be detected.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 applying to much force during the compression of the fracture.In this relation, following the operative technique can be pointed out: the compression screw tibia must be screwed in correctly and with reasonable forces to provide desired function and to avoid damage of implants / instruments.Deformation of the locking screw may indicate unreasonable force.¿ if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during the external apposition/compression procedure for t2 alpha tibia nail, the 42.5 mm locking screw that had been inserted into the proximal oval hole was bent.Screw removal was possible, but the operation time was prolonged by 30 minutes.".

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X42.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14165797
• Report Number: 0009610622-2022-00142
• Device Sequence Number: 12018147
• Product Code: HWC
• UDI-Device Identifier: 07613327366136
• UDI-Public: 07613327366136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 06/21/2022

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: 2360-5042S
• Device Catalogue Number: 23605042S
• Device Lot Number: K05CAF0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male