MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-FIX RCG STERILE PAC; ARTHROSCOPE

Catalog Number	014771
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an unknown procedure while using the drill and sleeve to drill through the glenoid bone in the shoulder via the glenoid drilling guide the drill of the product broke of in the bone.The fluted ends were exposed but the drill was still partly in the glenoid.A grasper was used to pull the drill out of the bone and removed from the patient.A new drill and sleeve was opened and the procedure continued with only a few minutes delay (3mins).All the drill parts were removed.A back up device was available and no patient injuries or significant delay were reported.
Additional Manufacturer Narrative
One (b)(4) t-fix sterile rcg drill pack reported on.Due to product unavailability, the product was not returned for evaluation.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.Therefore complaint could not be ultimately confirmed.If objective evidence or further relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Product met specifications upon release to distribution.Failures are monitored by surveillance.

• Brand Name: T-FIX RCG STERILE PAC
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8336732
• Report Number: 1219602-2019-00193
• Device Sequence Number: 16678601
• Product Code: HRX
• UDI-Device Identifier: 03596010446114
• UDI-Public: 03596010446114
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K925573
• 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): 03/17/2019

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: 014771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1