MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TW DRL F/COLE RAD DRL 4.0; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	110245
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during meta tan surgery, the twist drill for cole radiolucent drill 4.0 wobbled, as same as the first one, and failed to drill the third screw hole.The procedure was finished with a change in surgical technique, without inserting/tightening the third screw.It is unknown if there was a surgical delay.The patient was not injured beyond what has already been described.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is dull and worn, where it would attach to the corresponding instrument.The device shows signs of extensive use.The clinical/medical investigation concluded that without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TW DRL F/COLE RAD DRL 4.0
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10434286
• Report Number: 1020279-2020-04106
• Device Sequence Number: 2259420
• Product Code: HSB
• UDI-Device Identifier: 03596010034441
• UDI-Public: 03596010034441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• 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): 07/02/2021

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: 110245
• Device Catalogue Number: 110245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 07/02/2021
• 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: Required Intervention