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

Catalog Number	72202890
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopic, when the drill prepared the pilot hole, the drill tip got broken in the bone.Back-up device was used to complete the surgery.No delay was reported.Broken pieces remain in the patient's bone.Additional bone hole was required to complete the surgery.
Additional Manufacturer Narrative
One 2.5mm fluted drill w/ depth stop was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.The distal drill tip (approx.-.341) has broken from the shaft and was not returned.There are surface abrasions to the drills shaft in numerous locations.There is also damage to the chucking area of the drill consistent with slippage within the drill chuck during use.Dimensional assessment of the drill confirmed it met print specifications.The condition of the drill indicates it was subjected to excessive force during use.Per the device instructions for use under precautions: as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.

• Brand Name: 2.5MM FLUTED DRILL W/ DEPTH STOP
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8309846
• Report Number: 1219602-2019-00148
• Device Sequence Number: 1697462
• Product Code: HTW
• UDI-Device Identifier: 00885554038750
• UDI-Public: 00885554038750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72202890
• Device Lot Number: 50586163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 04/22/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/22/2019; 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1