MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill tip broke inside the patient and could not be removed.No back up device was available and no delay was reported.
Event or Problem Description
It was reported that the drill tip broke inside the patient and could not be removed.Procedure completed with the same device no delay was reported.
Event or Problem Description
It was reported that the drill tip broke inside the patient and could not be removed.Procedure completed with the same device no delay was reported.
Additional Manufacturer Narrative
The reported twist drill flex curved for 2.3 sa intended for use in treatment, will not be 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 drill tip broke inside the patient and could not be removed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: sudden starting and stopping of the drill bit in the bone may cause drill bit breakage.Application 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.There are no radiographs or medical documents provided for review.The retained drill bit tip is comprised of 17-4 stainless steel material.Based on astm and iso standards, the drill bit material composition would fall into a standardized medical grade alloy and, although not approved for implantation, standardized alloys have not been determined to cause injury or harm when the duration of contact with tissues/blood/bone is short-term, however, the drill tip (fragment) is not intended as an implantable device.As the location of the fragment was not reported, the future impact to the patient cannot be determined, since it is unknown if micro-motion could occur.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8601413
• Report Number: 1219602-2019-00537
• Device Sequence Number: 14043279
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: 03596010656018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 07/08/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 05/27/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1