MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE CANNULATED 7.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72203163
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an acl btb surgery the drill bit broke while attempting to drill, surgery was completed with a 7.0 mm flexible bit.Broken pieces were removed from the patient with a hemostat.No patient injuries or delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported 7.5mm flexible endoscopic cannulated drill bit was returned for evaluation.The drill is over five years old.Visual assessment of the drill confirmed the reported complaint of breakage.The drill has broken at the drill head tip pulse marks.No material voids are present at the break areas.The drills shaft is bent.The primary cutting edges are dull and dented.The cannulation is heavily burred.The condition of the device indicates the drill tip was likely worn prior to use contributing to the reported breakage.Per the device instruction for use under precautions: using a drill that is worn or has dull tips can result in breakage.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: DRILL FLEXIBLE CANNULATED 7.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9580581
• Report Number: 1219602-2020-00074
• Device Sequence Number: 491263
• Product Code: NBH
• UDI-Device Identifier: 03596010654564
• UDI-Public: 03596010654564
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 72203163
• Device Catalogue Number: 72203163
• Device Lot Number: 510963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/21/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1