MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE, 5.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72203161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the moment of drilling the tunnel of the femur with the drill, it broke.In order to solve the issue, the doctor used another drill bit, a hammer and a clamp, the broken drill was pushed to come out.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: DRILL, FLEXIBLE, 5.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7632492
• Report Number: 1219602-2018-00789
• Device Sequence Number: 16725521
• Product Code: NBH
• UDI-Device Identifier: 03596010654540
• UDI-Public: (01)03596010654540(10)50670348
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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 Model Number: 72203161
• Device Catalogue Number: 72203161
• Device Lot Number: 50670348
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 06/23/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR