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

Model Number	014771
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic laterjet, 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).I retrieved the drill parts to be analysed.
Additional Manufacturer Narrative
One 014771 t-fix sterile rcg drill pack reported on.The complaint stated: ¿the drill of the product broke off in the bone.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.Influences that could compromise product performance or integrity that are unrelated to manufacture include: entanglement with another instrument or device.Damaged or use of other than ifu recommended prep instrument size or types.Unexpected bone density/condition.Incompatible force or torque applied.The smith and nephew acufex t-fix rcg drill pac is designed to be used with the acufex t-fix rcg guide and acufex t-fix 1.8 mm x 9 mm suture bars.The drill and sleeves are provided sterile, for single procedure use only.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Careful attention must be paid to avoid excessive use of force on the drill and sleeves.Placing extreme forces on the drill and sleeves could result in device failure.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site registration number 1020279 (s+n memphis).The correct manufacturing site registration number is 1219602(s+n mansfield).Corrected data: g1 contact information.

• 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: 8274634
• Report Number: 1020279-2019-00259
• Device Sequence Number: 16658081
• 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,Followup,Followup
• Report Date (Section B): 02/08/2020

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 Expiration Date: 06/13/2023
• Device Model Number: 014771
• Device Catalogue Number: 014771
• Device Lot Number: 2017096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 03/04/2019; 02/08/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 01/30/2019; 03/05/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR