MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.5MM PEEK ZIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-200-035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
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 broken pieces were retrieved.
Event or Problem Description
It was reported that the anchor broke during the procedure.All broken pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: despite the use of an awl, the first anchor was broken off when the anchor was screwed in.The anchor and the broken part were then removed.When the second anchor it came to the fact that the anchor did not want to be placed, he was partially screwed and the surgeon dr.(b)(6) did not like the position and wanted to place him around.He did not turn back.Then he pulled out with a gripping instrument.When the third anchor it came to the one of the two belonging to the anchor threads when pulling out the setting instrument stuck to the setting instrument, there it is now, and then the anchor in the patient has remained and the doctor has performed the seam with only a thread of itself was still anchored.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on device, 2) bone too hard for anchor insertion, or 3) drill not inserted to proper depth.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
• MDR Report Key: 8491490
• Report Number: 0002936485-2019-00134
• Device Sequence Number: 2015245
• Product Code: MBI
• UDI-Device Identifier: 37613154644538
• UDI-Public: 37613154644538
• Combination Product (Y/N): N
• 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): 07/12/2019

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: 18102AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1