MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION SMITH & NEPHEW 2.6MM SPADE DRILL BIT FOR 2.3 ANCHOR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72201108

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 07/13/2016

Event Type  malfunction  

Event Description

Surgeon was using a smith & nephew drill bit from an osteoraptor set and piece broke off inside patient's shoulder.Surgeon was able to retrieve loose piece and an x-ray was obtained to assure all pieces were gathered from patient.

• Brand Name: SMITH & NEPHEW 2.6MM SPADE DRILL BIT FOR 2.3 ANCHOR
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 5821761
• MDR Text Key: 50395747
• Report Number: 5821761
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 72201108
• Device Lot Number: 50227297
• Other Device ID Number: OSTEORAPTOR 2.6MM SPADE DRILL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1