MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE CLANCY CURVED; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the device broke inside the bone.Backup device was available to complete the procedure.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
One flexible curved twist drills for 2.3 sa were returned for evaluation.Visual assessment of the drill confirmed the reported complaint of breakage.The entire drill head has broken free from the flexible cable link.The drill head was not returned for examination.The flex cable link is bent and slightly unwound.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied during use.Drill bit being operated in the reverse direction.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.
Additional Manufacturer Narrative
The reported curved clancy guide intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force.The instruction for use were reviewed and were 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.
Event or Problem Description
It was reported that during a procedure, the device broke inside the bone.The pieces were removed from the patient and a backup device was available to complete the procedure.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
Part number and udi number have been updated.

• Brand Name: GUIDE CLANCY CURVED
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8910020
• Report Number: 1219602-2019-00985
• Device Sequence Number: 11262654
• Product Code: NBH
• UDI-Device Identifier: 00885554023381
• UDI-Public: 00885554023381
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2019

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: 72203160
• Device Lot Number: 50609199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 09/16/2019; 10/18/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/17/2019; 10/18/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1