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

Catalog Number CAT01860

Device Problem Positioning Problem (3009)

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

Event Date 08/26/2021

Event Type  Injury  

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: use of excessive force or improper reprocessing cycles/agents used.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is unknown.

Event Description

It was found that a piece of the device had broken off.The piece could potentially have remained in the patient.

• 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
• 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: 12817046
• MDR Text Key: 280831404
• Report Number: 0002936485-2021-00629
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2021

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: 341203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other