MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; STAPLE, FIXATION, BONE

Model Number	72203160
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during shoulder lip repair procedure, the flexible drill broke during pull out the drill.The broken piece was removed from the patient and 3 hours delay was reported.The procedure was successfully completed with a back-up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: one 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 damage is where the spiral drill tip is welded to the stranded flex cable.It is consistent with a fractured weld.Torque was a factor.The drill should be used in continuous rotation while drilling inward and retreating.The flex cable composition is reactive to inadvertent torque overload (sudden starts and stopping or switching between forward and reverse rotations), twisting and bending.The distal portion and blades have scratches and dings aligned with contact with another instrument or device.The stranded section has also been forced out of alignment with the shaft.The instrument is intended to flex but not bend.Per instructions for use: ¿these instruments are intended for repeated use with proper care and handling.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Maintaining guide alignment throughout drilling is required to ensure drill bit integrity.It is recommended to drill in one continuous motion to prepare the site.Sudden starting and stopping of the drill bit in the bone may cause drill bit breakage.¿ no root cause related to the manufacture of the device was confirmed.Complaint history review indicated no similar allegations for the lot number reported.Device history review/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302720
• Report Number: 1219602-2019-01400
• Device Sequence Number: 2172148
• Product Code: JDR
• 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
• Report Date (Section B): 02/19/2020

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 Expiration Date: 03/22/2023
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50722641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1