MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.5MM PEEK ZIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-200-035
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that anchor broke during the procedure.All pieces were retrieved.
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: break.Probable root cause: design: anchor not compatible with prepared hole size; drill design does not match anchor; anchor thread design makes insertion too difficult; inserter material/design too weak; inserter tip geometry not sharp enough for application.Process: inserter, implant, or drill manufactured out of specification.Application: excessive force torquing anchor or lateral force applied during insertion; not enough axial force during insertion; use of wrong drill; improperly prepared hole; bone to hard for anchor insertion; bone not hard enough to maintain screw purchase; no pilot hole prepared; drill not inserted to proper depth.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that anchor broke during the procedure.All pieces were retrieved.

• Brand Name: 5.5MM PEEK ZIP
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17769605
• Report Number: 0002936485-2023-00944
• Device Sequence Number: 15312830
• Product Code: MBI
• UDI-Device Identifier: 37613154644538
• UDI-Public: 37613154644538
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-200-035
• Device Lot Number: 23095AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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
• Patient Sex: Male