MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	656414S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	09/10/2021
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: "when inserting the bone screw into the proximal hole, the screw broke at the head.The operation was completed by inserting another screw while the screw tip remained in the body." the tip of screw remains in patient.No adverse impact to the patient reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the affected device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the whole threaded portion of the implant is missing.The head of the screw is completely deformed which indicate use of force on the device.Since complete device is not available, surface of the breakage cannot be analyzed thoroughly.However, the clear deformation of the center portion indicated mis locking with use of slightly high force for removal lead to the breakage.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities & clear indication in labelling that ¿when final tightening of the locking screw occurs, take care not to over-torque the screw.Excessive torque may damage the locking mechanism, the screw and/or the screwdriver blade.¿ based on investigation, the root cause was primarily attributed to be user related along with patient factor such as hard/dense bone.The breakage was caused due to application of slightly high force to remove screwdriver from screw head which might be stuck due to mis locking.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when inserting the bone screw into the proximal hole, the screw broke at the head.The operation was completed by inserting another screw while the screw tip remained in the body." the tip of screw remains in patient.No adverse impact to the patient reported.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12568383
• Report Number: 0008031020-2021-00423
• Device Sequence Number: 11684168
• Product Code: HWC
• UDI-Device Identifier: 07613327070873
• UDI-Public: 07613327070873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180500
• 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): 01/18/2022

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 Expiration Date: 10/28/2025
• Device Model Number: 656414S
• Device Catalogue Number: 656414S
• Device Lot Number: 1000423156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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: 25 YR
• Patient Sex: Male