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

Catalog Number	72203160
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the surgeon was drilling through drill guide and the drill was pulled out, the drill was hard to pull back out and the tip of the drill broke.The broken piece was removed from the patient.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One 72203160 flexible curved twist drill (2.6mm) for 2.3mm suture anchor used for treatment, was returned for evaluation.The drill has broken at the distal end.The breakage is where the spiral drill tip is welded to the hollow stranded flex cable.It is consistent with a compromised weld.The flex cable beginning to fray is aligned with being run in reverse.Force was a factor.The instrument is intended to flex but not bend.The flex cable composition is reactive to inadvertent torque overload (sudden starts and stopping or switching between forward and reverse rotations), twisting and bending.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• 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: 8895071
• Report Number: 1219602-2019-00966
• Device Sequence Number: 286522
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1