MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	656416
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported the following issue: "the operating room reported an incident on (b)(6) 2021 with 2 cortical screws reference (b)(4).The 2 screws broke before reaching the end of their travel.It was necessary to core drill to extract them." additional information received - 11/08/2021: surgical delay (approx.20 min) and need for coring to remove broken screws.Adverse impact on patient: bone fracture at the coring site.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: 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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
Customer reported the following issue: "the operating room reported an incident on (b)(6) 2021 with 2 cortical screws reference 656416.The 2 screws broke before reaching the end of their travel.It was necessary to core drill to extract them." ***additional information received - (b)(6)2021: surgical delay (approx.20 min) and need for coring to remove broken screws.Adverse impact on patient: bone fracture at the coring site.

• Brand Name: BONE SCREW, T8 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12844489
• Report Number: 0008031020-2021-00471
• Device Sequence Number: 11869604
• Product Code: HWC
• UDI-Device Identifier: 07613327068856
• UDI-Public: 07613327068856
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 656416
• Device Catalogue Number: 656416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown