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	02/26/2021
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 remains in the patient.Note, the piece of the broken screw that remains in the patient is securely implanted.
Event or Problem Description
Please note that the initial report's type of reportable event was serious injury; per additional information received, the event description most likely indicates screw advancement force too large, screw plunges.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury therefore making this event not reportable.
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: anchor broken 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; inadequate design relationship between awl size and screw; inadequate design relationship between eyelet size and screw; 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; 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.Please note that the initial report's type of reportable event was serious injury; per additional information received, the event description most likely indicates screw advancement force too large, screw plunges.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury therefore making this event not reportable.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
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: anchor broken.Probable root cause: application: user applies excessive force to torque screw.User does not drill/tap pilot hole.User does not go to laser line.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 remains in the patient.Note, the piece of the broken screw that remains in the patient is securely implanted.

• 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
• MDR Report Key: 11575045
• Report Number: 0002936485-2021-00175
• Device Sequence Number: 14358028
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/29/2021

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: 20226AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 02/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/23/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other