MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR TWINFIX ULTRA 4.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72202633
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the tip broke in the patient's bone, it was not possible to remove the tip.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.The 17 4ph ss is not an implantable alloy; therefore, long term implantation data is not available.The patient impact beyond possible micro motion and/or migration, local irritation/discomfort, and possible mri restrictions cannot be determined, as it was reported the patient¿s current status was unknown and the broken fragment/foreign body could not be removed from the bone.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review device labeling (including technique guides, ifus, etc.) clinically relevant supporting documentation was not provided for inclusion in a medical investigation.It was communicated that the instrument tip fractured into good (quality) bone and was retained.It was further communicated that the procedure was completed with a backup device and the patient¿s current status remains unknown, although it was reported that it was not possible to remove the ¿part that broke¿ from the bone.The material composition of the externally communicating device is reported as 17-4ph stainless steel and is not approved for implantation, and when used per manufacturing guidelines, should have limited exposure (< 24 hours) to bone and tissue.In conclusion: without instrument return and evaluation or other clinically relevant documentation, the root cause of the fractured instrument could not be concluded.The location and size of the retained awl tip/foreign body remains unknown as well as if micromotion of the retained foreign body is likely.The 17-4ph ss is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and possible mri restrictions cannot be determined, as it was reported the patient¿s current status was unknown and the broken fragment/foreign body could not be removed from the bone.No further medical assessment can be rendered at this time.Mi report approved by md (b)(6) on (b)(6) 2019.In conclusion: without instrument return and evaluation or other clinically relevant documentation, the root cause of the fractured instrument could not be concluded.The location and size of the retained awl tip/foreign body remains unknown as well as if micromotion of the retained foreign body is likely.The 17-4ph ss is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and possible mri restrictions cannot be determined, as it was reported the patient¿s current status was unknown and the broken fragment/foreign body could not be removed from the bone.No further medical assessment can be rendered at this time.

• Brand Name: AWL-DILATOR TWINFIX ULTRA 4.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8242714
• Report Number: 1219602-2019-00069
• Device Sequence Number: 1697292
• Product Code: NBH
• UDI-Device Identifier: 03596010647634
• UDI-Public: 03596010647634
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 03/22/2019

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: 72202633
• Device Lot Number: 50553718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR