MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L36MM; PLATE, FIXATION, BONE

Catalog Number	371536
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
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
It was reported, the threads on the two locking guides, reference (b)(4) , are in poor condition.This issue causes incorrect screw alignment because the system is uniaxial and alters the direction of the locking screw.As a result, when attempting to insert a 4.0x36mm locking screw, reference (b)(4) , the force and the change in the alignment of the locking guide caused the screw head to break off, leaving it inside the patient.A surgical delay of 15-20 minutes was reported.
Additional Manufacturer Narrative
Correction - please refer to d9 - the product was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, the threads on the two locking guides, reference 702707, are in poor condition.This issue causes incorrect screw alignment because the system is uniaxial and alters the direction of the locking screw.As a result, when attempting to insert a 4.0x36mm locking screw, reference 371536, the force and the change in the alignment of the locking guide caused the screw head to break off, leaving it inside the patient.A surgical delay of 15-20 minutes was reported.

• Brand Name: LOCKING SCREW AXSOS 4.0MM / L36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20362947
• Report Number: 0009610622-2024-00846
• Device Sequence Number: 6878018
• Product Code: HRS
• UDI-Device Identifier: 07613154864263
• UDI-Public: 07613154864263
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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 Catalogue Number: 371536
• Device Lot Number: AB6873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 60 KG