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	02/25/2021
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.
Additional Manufacturer Narrative
Alleged failure: it was reported by sales rep (b)(6) that allegedly the 4.75 omega single anchor screw broke 1/3 into dialing it in.Reportedly during an open glute repair for a 69 yr old female.Allegedly we drilled and used the tap prior to insertion.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) user does not drill/tap pilot hole, 3) user does not go to laser line (incomplete tapping/drilling/awling), 4) use of incorrect drill size for associated screw, or 5) inadequate assessment of bone quality.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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: 11586767
• Report Number: 0002936485-2021-00181
• Device Sequence Number: 11973365
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 04/23/2021

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: 20301AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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: 69 YR