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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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
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.
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: 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.The reported failure mode will be monitored for future reoccurrence.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
• MDR Report Key: 11655696
• Report Number: 0002936485-2021-00210
• Device Sequence Number: 14326502
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 05/03/2021

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: 20020AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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
• Patient Age: 70 YR