MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-100-035
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a breach in the sterile barrier.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was a breach in the sterile barrier.
Additional Manufacturer Narrative
Alleged failure: during the reception, it was detected that the medical device was not sterilized.The packaging was open, therefore it lost sterility the failure(s) identified in the investigation is consistent with the complaint record.The root cause is a manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM
• 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: 18881437
• Report Number: 0002936485-2024-00210
• Device Sequence Number: 9050854
• Product Code: MBI
• UDI-Device Identifier: 37613154015307
• UDI-Public: 37613154015307
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K041310
• 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): 07/08/2024

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: Other
• Device Catalogue Number: 3910-100-035
• Device Lot Number: 23140AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2023
• 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
• Patient Sex: Unknown