MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 6.5MM PEEK ZIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-200-075

Device Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material in the sterile packaging.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: on a 6.5mm peek zip, the anchor came out of the sterile package with red marks on the anchor.The probable root causes could be: 1) improper handling during product removal from packaging or 2) uncontrolled environmental conditions.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was foreign material in the sterile packaging.

• Brand Name: 6.5MM PEEK ZIP
• Type of Device: 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: 12474763
• MDR Text Key: 272662888
• Report Number: 0002936485-2021-00502
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613154644552
• UDI-Public: 37613154644552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-200-075
• Device Lot Number: 20231AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1