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	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery the twist drill gave of lots of metal debris when drilling anchor holes, all the metal was removed from the joint.The procedure was successfully completed using a back-up device.A delay of 5 minutes was reported.No patient injury or 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 72203160 twist drill for 2.3mm suture anchors was used for treatment but was not returned for evaluation.Instructions for use (ifu) contains precautionary statements and recommendations for proper use of product.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.Per ifu ¿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.Note: the depth stop on the drill bit for the suture anchor bottoms out on the proximal end of the curved guide when proper hole depth is reached.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• 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: 9999626
• Report Number: 1219602-2020-00692
• Device Sequence Number: 3071088
• Product Code: JDR
• UDI-Device Identifier: 03596010656018
• UDI-Public: 03596010656018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/27/2020

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 Expiration Date: 05/17/2023
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50736381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: Other