MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG, NANOTACK FLEX GUIDE; ACCESSORIES, ARTHROSCOPIC

Catalog Number CAT01860

Device Problem Device Slipped (1584)

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

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that a piece of the device potentially broke during the procedure and remains in the patient.

Event Description

It was reported that a piece of the device potentially broke during the procedure and remains in the patient.

Manufacturer Narrative

Alleged failure: during a hip labral repair, the nanotack flex drill guide created an uncentered drill hole which the anchor inserter would not follow the same path.The doctor switched to another drill guide which solved the issue.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive bending force on guide,excessive force applied on device, rough handling during reprocessing, or 4) improper reprocessing cycles/agents used.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: FG, NANOTACK FLEX GUIDE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11346341
• MDR Text Key: 232505063
• Report Number: 0002936485-2021-00094
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT01860
• Device Lot Number: 319108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other