MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 3.9MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-392
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 and pieces remained in the patient.
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: implant failure.Probable root cause: design: inadequate driver/handle interface design.Inadequate driver/knob interface design.Inadequate screw/driver interface design.Inadequate raw material for driver tip, shaft, knob, handle or screw.Inadequate surface finish for driver/knob interface.Inadequate screw thread design for bone engagement or suture interface.Inadequate design relationship between tap and screw (causing previous screw insertion to be difficult, twisting the driver).Inadequate design relationship between awl size and screw (causing previous screw insertion to be difficult, twisting the driver).Inadequate design relationship between eyelet size and screw (causing previous screw insertion to be difficult, twisting the driver).Inadequate design relationship between screw and versitomic reamer.Process: tap or screw not manufactured to specification.Driver not manufactured to specification.Knob or driver handle not manufactured to specification.Incorrect material used during manufacturing.Incorrect assembly performed for screw/driver or knob/driver.Screw assembled upside down.Application: user applies excessive force to torque screw.User does not drill/tap pilot hole.User does not go to laser line (incomplete tapping/drilling/awling).Inadequate assessment of bone quality.User re-loads a new screw upside down.Use of incorrect drill size for associated screw.Eyelet causes interference with screw during insertion.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that the screw broke during the procedure and pieces remained in the patient.

• Brand Name: OMEGA 3.9MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE
• 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: 12977683
• Report Number: 0002936485-2021-00704
• Device Sequence Number: 4883916
• Product Code: MBI
• UDI-Device Identifier: 37613327464802
• UDI-Public: 37613327464802
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 3910-500-392
• Device Lot Number: 20266AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown