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

Catalog Number	72203163
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while making the femur tunnel, when the flexible drill touched the bone it broke.Everything was removed from the patient using a hemostat.The procedure was successfully completed without significant delay using a back-up device.In the same bone hole.No other complications were 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: one 7223163 drill flexible cannulated 7.5mm used for treatment, was not returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.The complaint stated: ¿during surgery, while making the femur tunnel, when the flexible drill touched the bone it broke¿.Product manufacturing documentation shows that the complaint devices met specifications upon release to distribution.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.

• Brand Name: DRILL FLEXIBLE CANNULATED 7.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10112658
• Report Number: 1219602-2020-00838
• Device Sequence Number: 2626206
• Product Code: NBH
• UDI-Device Identifier: 03596010654564
• UDI-Public: 3596010654564
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203163
• Device Lot Number: 50423016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention