MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201108

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that during a hip arthroscopy they inserted the drill guide into left hip, placed anchor in the drill hole, and went to check placement with x-ray.At that point the surgeon identified the metal tip in the hip (which hadn't been seen on previous x-ray).The drill guide tip had snapped during surgery in the patient's hip.The fragment was embedded in the bone next to the suture anchor and there are no plans to remove it.No patient injury or complications were noted post operatively.It was stated that the patient would be following up with their physician.

Manufacturer Narrative

One 2.6mm fluted drill with depth stop was returned for evaluation.Visual assessment of the drill confirmed the breakage.The entire drill head has broken off.The break area shows no material voids or abnormalities.The shaft is it is scored in a circular manner at proximal to the break area.There is damage to the chucking area of the drill consistent with slippage within the drill chuck during use.Dimensional inspection of all attributes of the drill that could be measured was found to meet print specifications.Drill was tested for material condition and confirmed to meet specification.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation the root cause for the reported issue could not be determined.No further investigation is warranted at this time.(b)(4).

• Brand Name: DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5368150
• MDR Text Key: 36340606
• Report Number: 1219602-2016-00030
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

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: Health Professional
• Device Expiration Date: 12/29/2010
• Device Catalogue Number: 72201108
• Device Lot Number: 50359218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1