MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOTACK SUTURE ANCHOR 1.4MM WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	CAT01386
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the anchor broke during the procedure and remained in the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
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: anchor broke probable root cause: design -inserter/implant not compatible with guide -inserter material/design too weak -inserter shaft cannot bend around curved guide -guide mouth not designed to grip bone -guide not able to be gripped tightly - clearance between anchor coupling and inserter id too large (leads to anchor decoupling from the inserter) - inserter tube wall thickness too thin process -inserter, implant, and/or guide manufactured out of spec -anchor not assembled properly to inserter application -excessive force impacting inserter -movement of guide out of orientation - guide buried into bone the reported failure mode will be monitored for future reoccurrence.81.
Event or Problem Description
It was reported that the anchor broke during the procedure and remained in the patient.

• Brand Name: NANOTACK SUTURE ANCHOR 1.4MM WITH INSERTER
• 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: 15620991
• Report Number: 0002936485-2022-00595
• Device Sequence Number: 6224732
• Product Code: MBI
• UDI-Device Identifier: 07613252633006
• UDI-Public: 07613252633006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: CAT01386
• Device Catalogue Number: CAT01386
• Device Lot Number: 22047AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown