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 Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
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 the anchor broke during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: anchor is broken during insertion into soft bone.Replacement was available.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force or 2) no pilot hole prepared.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13006305
• Report Number: 0002936485-2021-00712
• Device Sequence Number: 11970763
• Product Code: MBI
• UDI-Device Identifier: 37613154644538
• UDI-Public: 37613154644538
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K070758
• 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): 01/26/2022

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: 21155AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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: Unknown