MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-471
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the screw broke during the procedure.The broken screw remains in the patient's bone.
Event or Problem Description
It was reported that the screw broke during the procedure.The broken screw remains in the patient's bone.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: screw broken.Probable root cause: design: inadequate raw material selection for screw.Design geometry too sensitive to withstand clinical impaction loads.Screw/driver interface not designed to maintain proper assembly.Process: screw or driver not manufactured to specification.Incorrect material used during manufacturing.Screw and driver not assembled to specification.Application: excessive force or leveraging of the screw against the bone.Inadequate assessment of bone quality, pilot hole not prepared.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15201169
• Report Number: 0002936485-2022-00452
• Device Sequence Number: 4800305
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181083
• 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): 09/28/2022

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 Catalogue Number: 3910-500-471
• Device Lot Number: 21306AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2022
• Supplement Date Received by Manufacturer: 07/16/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/29/2022
• 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: Other
• Patient Sex: Unknown