MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 VARIABLE ANGLE DRILL GUIDE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71364477
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection did not confirm the end is jammed.A visual inspection of the returned drill guide did confirm the tip of the device is broken.The instrument exhibits signs of significant use and wear.A supplemental mdr with the results of investigation of the pending activities will be sent.(b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the end of an r3 variable angle drill guide was jammed.The surgery was resumed, without any delay, with a back-up device.The patient was not injured as consequence of this problem.The investigation found that the tip of the device is broken.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection did not confirm the end is jammed.A visual inspection of the returned drill guide did confirm the tip of the device is broken.The instrument exhibits signs of significant use and wear.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 VARIABLE ANGLE DRILL GUIDE
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12759120
• Report Number: 1020279-2021-07860
• Device Sequence Number: 3133516
• Product Code: JDG
• UDI-Device Identifier: 03596010599452
• UDI-Public: 03596010599452
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Model Number: 71364477
• Device Catalogue Number: 71364477
• Device Lot Number: 15HM10620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown