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

Catalog Number 72202890

Device Problems Break (1069); Metal Shedding Debris (1804)

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

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hip labrum repair procedure, metal powder was noticed after drilling the first anchor, and while drilling the second anchor the tip of the device broke.The broken pieces were removed from the patient.A back up device was not required, as the surgeon felt there was enough fixation with the first anchor.No patient injury or complications were reported.

Manufacturer Narrative

Examination was not possible, as the device was not made available to the manufacturer.However, the device was sent out for testing in (b)(6) by the hospital.The testing results determined that excessive force was placed on the device causing the breakage.A review of manufacturing records found no deficiencies during the manufacturing process.

• Brand Name: 2.5MM FLUTED DRILL W/ 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: 5784104
• MDR Text Key: 49639927
• Report Number: 1219602-2016-00367
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202890
• Device Lot Number: 50426553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1