MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	234-102-060
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
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 device broke during procedure and was potentially unable to be retrieved from patient.
Event or Problem Description
It was reported that the device broke during procedure and was potentially unable to be retrieved from patient.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: broken during surgery.Probable root cause: design - loop material too weak - loop size too small to facilitate ease of graft loading into loop.Process - use of incorrect materials during assembly - loop splicing not performed to specification causing loop to be too small.Application - excessive manipulation/force.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING
• 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: 16258750
• Report Number: 0002936485-2023-00069
• Device Sequence Number: 17839113
• Product Code: MBI
• UDI-Device Identifier: 07613327137385
• UDI-Public: 07613327137385
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150416
• 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): 03/11/2023

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: 234-102-060
• Device Catalogue Number: 234-102-060
• Device Lot Number: 22222AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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