MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1.4MM DISPOSABLE DRILL; BIT, DRILL

Catalog Number 3910-500-568

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was debris in the joint.The debris was flushed out of the joint and the procedure was completed successfully.

Manufacturer Narrative

Alleged failure: this was reported on 6-20-2019.Surgeon was drilling for 7th iconix 1 anchor at the 11 oclock position of a bankart/slap repair.Bone quality was soft-normal.Went to put iconix anchor in after drilling pilot hole and could not advance anchor into the guide.At that point we noticed there was debris left in the guide from the drill bit.Were able to remove the pieces from the guide and have included those in return packaging.Pieces not included had to be removed from the joint with shaver and suction.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on drill, 2) starting and stopping drill, 3) pulling drill out of bone without running drill, or 4) moving drill guide during drilling.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was debris in the joint.The debris was flushed out of the joint and the procedure was completed successfully.

• Brand Name: ICONIX 1.4MM DISPOSABLE DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8789528
• MDR Text Key: 151054051
• Report Number: 0002936485-2019-00297
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 37613252450499
• UDI-Public: 37613252450499
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-568
• Device Lot Number: 19073AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 102