MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP LABRAL REPAIR; 2.5MM FLUTED DRILL W/ DEPTH STOP

Model Number 72202890

Device Problems Break (1069); Device Markings/Labelling Problem (2911); Material Protrusion/Extrusion (2979)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/13/2015

Event Type  Injury  

Event Description

During a hip arthroscopy it was reported that while drilling a hole into rim of the acetabulum the surgeon drilled through a spike tip drill guide.When surgeon removed the drill bit he noticed that only half of the bit was removed and the other half was still in the hole.He did a search and found that the broken drill bit was protruding through the articular cartilage.The broken piece was removed with a grasper.The surgeon believed that after the bit broke, what was left of the shaft of the bit essentially changed its trajectory (no longer being engaged in the drill hole) and created a small rim fracture due to the proximity of the drilled hole to the acetabulum.He didn't blame the bit.However, the weakened metallurgy and the proximity of the drill hole to the articular surface made for a bad combo.It was noticed the bit was lacking of any legible markings.Customer thinks it had been processed a couple hundred times.They do about 250-300 labral repairs a year.Surgeon put an anchor in above the defect and secured the labrum.

Manufacturer Narrative

Although anticipated, the device has not been received for analysis.(b)(4).

• Brand Name: HIP LABRAL REPAIR
• Type of Device: 2.5MM FLUTED DRILL W/ DEPTH STOP
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: donna lanteigne ; 150 minuteman road; andover, MA 01810 ; 9787491576
• MDR Report Key: 4578864
• MDR Text Key: 5553526
• Report Number: 1219602-2015-00038
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

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 Model Number: 72202890
• Device Catalogue Number: 72202890
• Device Lot Number: 50476397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/06/2015
• Date Device Manufactured: 09/25/2013
• 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