MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING; PIN, FIXATION, SMOOTH

Model Number	234-102-060
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
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 implant broke during the procedure.No pieces fell into the joint.
Additional Manufacturer Narrative
Alleged failure: the implant breaks when it is being raised and cannot be used properly.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied device.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 implant broke during the procedure.No pieces fell into the joint.

• Brand Name: PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10635007
• Report Number: 0002936485-2020-00405
• Device Sequence Number: 2604616
• Product Code: HTY
• UDI-Device Identifier: 07613327137385
• UDI-Public: 07613327137385
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150416
• 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): 12/04/2020

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 Model Number: 234-102-060
• Device Catalogue Number: 234-102-060
• Device Lot Number: 20062AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR