MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,2.6 FLUTED DR W/2.5 SHORT DEPTH STOP; BIT, DRILL

Catalog Number 72203284

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a hip arthroscopy procedure it was reported that the tip of the drill bit broke off.The tip is still in the patient's bone.This was discovered during the last part of the procedure; they took a last x-ray and saw the piece.The surgeon does not know when this occurred, but they assume it was when the last anchor was placed.

Manufacturer Narrative

One 2.6mm fluted drill with depth stop was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.Approximately one half inch of the drill tip has broken off and was not returned for examination.The break shows no material voids.The drill is scored in a circular manner in several places along its length and shows signs or normal wear.Dimensional inspection of all attributes of the drill that could be measured were found to meet print specifications.Drill was tested for material condition and confirmed to meet print specification.Without the return of the broken drill head a root cause cannot be established.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: MTO,2.6 FLUTED DR W/2.5 SHORT DEPTH STOP
• Type of Device: BIT, DRILL
• 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: 5067734
• MDR Text Key: 26025051
• Report Number: 1219602-2015-00976
• Device Sequence Number: 1
• Product Code: HTW
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/21/2015

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 Catalogue Number: 72203284
• Device Lot Number: 50421066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR