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

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was found that a piece was broken and missing from the device.It was unable to be determined if this occurred during a procedure, however upon intake it was indicated that no pieces were left in the patient.

Event Description

It was found that a piece was broken and missing from the device.It was unable to be determined if this occurred during a procedure, however upon intake it was indicated that no pieces were left in the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: the tip of the anchor was locked.The probable root cause could be user applies excessive force or off axial force significant enough to bind anchor/inserter.The failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM
• 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: 14294704
• MDR Text Key: 290975415
• Report Number: 0002936485-2022-00211
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613154015307
• UDI-Public: 37613154015307
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K041310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-100-035
• Device Lot Number: 20050AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• 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
• Patient Sex: Male