MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSY PKG TWINLOOP PEEK 3.5MM W/ONE NO. 2 FORCE FIBER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-400-035
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
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.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.This investigation will be closed based on probable root cause.Alleged failure: screw broke.Customer complaint: biosteon screw & twinloop anchor broke during surgery.Investigation findings are: this case involved the use of two different screws of different sizes in addition to a stryker product, twin loop anchor, consisting of peek material.This would insinuate that the cause of breakage in linked to the technique used.Information provided was too limited to fulfil a detailed investigation.Numerous attempts were made to gather more information.Warnings and precautions, including prevention of screw breakages are stated in the instructions for use.No medical intervention is specified, however neither is the effect of the issue on the patient.The suspected root causes are: unable to confirm.The corrective action: no corrective action possible due to lack of information from complainant.The preventive action: h3 other text : 81.
Event or Problem Description
It was reported that the anchor broke during the procedure.All pieces were retrieved.

• Brand Name: ASSY PKG TWINLOOP PEEK 3.5MM W/ONE NO. 2 FORCE FIBER
• 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: 12374111
• Report Number: 0002936485-2021-00472
• Device Sequence Number: 14354869
• Product Code: MBI
• UDI-Device Identifier: 34546540678219
• UDI-Public: 34546540678219
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K070882
• 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): 10/11/2021

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: 3910-400-035
• Device Lot Number: BS200501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1