MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR TWINFIX ULTRA 5.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202634
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while performing a proximal hamstring repair, prior to placing a healicoil anchor into the ischial tuberosity, the surgeon prepped the hole using a s&n healicoil tap, while screwing in or unscrewing the tap, the shaft broke off the threaded portion/ tip leaving the threaded portion inside the patients bone.The surgeon then had to remove the threaded portion/ tip from the bone.The case was completed using qfix anchors and not with the intended healicoil anchors with a delay greater than 30 minutes.No 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
One 72202634 5.5mm twinfix ultra awl-dilator used in treatment was returned for evaluation.This is a twinfix awl dilator intended for use during 5.5mm to 6.5mm twinfix anchor device prep.It is a seven year old reusable instrument.It was reportedly and inadvertently used for a healicoil procedure prep.There was substantial damage noted.The dilator had been used for leverage at some point.The entire shaft was bent at the handle.The threaded distal portion was completely severed off the shaft.Water and bio stains on the fracture surfaces indicate that the instrument was already compromised prior to use.Recommended maintenance was not adhered to.There were skived threads with evidence of contact with other devices and instrument tooth marks.Per instructions for use: ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.These instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.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.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacturing of the devices was confirmed.Product met specifications upon release to distribution.

• Brand Name: AWL-DILATOR TWINFIX ULTRA 5.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10455032
• Report Number: 1219602-2020-01317
• Device Sequence Number: 11652218
• Product Code: NBH
• UDI-Device Identifier: 03596010647641
• UDI-Public: 03596010647641
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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 Model Number: 72202634
• Device Catalogue Number: 72202634
• Device Lot Number: 50457524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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: Hospitalization; Required Intervention