MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW IMN SCREWS Ø5X50MM; SCREW, FIXATION, BONE

Model Number	2360-5050S
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported the "t2 alpha 5mm locking screws bent while applying compression." **update: this incident happened during t2 alpha tibial nail.The bent screw had to be removed before proceeding with the surgery.The surgery was completed but there was a delay with removing the bent screw and proceeding.
Additional Manufacturer Narrative
Please note correction to h6 health impact code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was found to be damaged around the threads in the middle.The threads are plastically deformed & the screw is excessively bent.These damages indicate towards an application of excessive forces while compressing.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The optech states that; ¿caution the compression screw must be screwed in correctly and with reasonable force to provide desired function and to avoid damage of implants/instruments.Deformation of the locking screw may indicate unreasonable force.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by an application of excessive force while compressing.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported the "t2 alpha 5mm locking screws bent while applying compression." update: this incident happened during t2 alpha tibial nail.The bent screw had to be removed before proceeding with the surgery.The surgery was completed but there was a delay with removing the bent screw and proceeding.Update: the delay was approximately 10 minutes.

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X50MM
• 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: 13635964
• Report Number: 0009610622-2022-00076
• Device Sequence Number: 14756399
• Product Code: HWC
• UDI-Device Identifier: 07613327366235
• UDI-Public: 07613327366235
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/27/2022

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: 2360-5050S
• Device Catalogue Number: 23605050S
• Device Lot Number: K03AE1B
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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 Sex: Unknown