MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T10 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	657116S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "screw head broke off while introducing.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
Please note corrections to h6 (method code, results codes, and conclusion 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 shows significant signs of usage, the screw is completely broken near the head region and only proximal part is available for analysis.The broken surface is ductile in nature, evident by a cup & cone shape which can be seen on the breakage area, and it was caused due to torsional and bending overload.Slight decolorization was observed on the bottom of the screw head gives indication that the screw was overtightened on the plate.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.Based on the investigation, the root cause was attributed to a user-related issue.The failure was most likely caused by improper insertion of the screw (intra-operative) into the plate leading towards application of high torsional and bending load which resulted into breakage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "screw head broke off while introducing.".
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device will be returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.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 device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "screw head broke off while introducing.".

• Brand Name: BONE SCREW, T10 FULL THREAD, 2.7MM/L16MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16537275
• Report Number: 0008031020-2023-00111
• Device Sequence Number: 6264944
• Product Code: HWC
• UDI-Device Identifier: 07613327071542
• UDI-Public: 07613327071542
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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: 07/10/2024
• Device Model Number: 657116S
• Device Catalogue Number: 657116S
• Device Lot Number: 1000364352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 06/06/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/26/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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