MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOTACK SUTURE ANCHOR 1.4MM W/ FLEX INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number CAT01858

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the inserter broke and part of it remained embedded in the bone.

Event Description

It was reported that the tip of the inserter broke and part of it remained embedded in the bone.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: break and remained in bone probable root cause: design -inserter shaft/handle design/material too weak - nanotack tt inserter slot causes a weak spot on the shaft - interface between anchor/guide too tight -inserter shaft cannot bend around curved guide - deployment mechanism assembly design not able to support deployment loads process -inserter and/or guide manufactured out of specification - inserter deployment mechanism not assembled to specification - debris left in/on the device during manufacturing application -excessive force impacting anchor the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: NANOTACK SUTURE ANCHOR 1.4MM W/ FLEX INSERTER
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15658385
• MDR Text Key: 302269145
• Report Number: 0002936485-2022-00616
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT01858
• Device Catalogue Number: CAT01858
• Device Lot Number: 22132AE3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White