MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR 4.5MM HEALICOIL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the device was broken.No backup device was available.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
One healicoil 4.5mm dilator awl reported on.The product was used for treatment but was not returned for evaluation.This complaint is for a four year old reusable instrument.Due to product unavailability, physical evaluation, full investigation and conclusions were not definitive.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device ability, use methods, procedure location, bone condition, care and cleaning.Influences that could compromise product performance or integrity that are unrelated to manufacture include: unexpected bone condition/density.Condition, age and care of reusable product.Inadvertent stress, pressure or excess torque applied.Handle degradation due to unapproved cleaning agents.Per instructions for use: ¿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¿.The delrin handle material is subject to drying, etching and degradation from use of incompatible cleansing agents.Per instructions for use:¿low-sudsing, neutral 6.0¿8.0 ph, enzymatic detergents are recommended.Do not use detergents above 11.0 ph.Use deionized water for washing and rinsing.Use deionized water for washing and rinsing¿.With reusable instruments, it is unknown whether the recommended sterilization has been applied consistently.No root cause related to the manufacturing of this device was confirmed.Product met specifications upon release to distribution.

• Brand Name: AWL-DILATOR 4.5MM HEALICOIL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8885722
• Report Number: 1219602-2019-00955
• Device Sequence Number: 2534140
• Product Code: MBI
• UDI-Device Identifier: 00885554025828
• UDI-Public: 00885554025828
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K110545
• 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): 09/02/2019

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: 72203335
• Device Lot Number: 50550337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1