MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN SURESHOT DISTAL TARGETING SYST DRILL BIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71440209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, the gii slt 3 mod tib cutblck lt while drilling holes, the drill bit broke off inside the hold.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.No further complications were reported.
Event or Problem Description
It was reported that, during a tka surgery, the gii slt 3 mod tib cutblck lt while drilling holes, the trigen sureshot distal targeting syst drill bit broke off inside the hold.Surgery was resumed, without any delay, with a smith and nephew back-up device.Patient was not harmed.No further complications were reported.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be broken and lodged within the cutting block, rendering the device inoperative.The rest of the drill bit was not returned.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 contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to surgical technique used or user/procedural variance.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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Corrected data: h6 - code 2199 removed.

• Brand Name: UNKN TRIGEN SURESHOT DISTAL TARGETING SYST DRILL BIT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 13926977
• Report Number: 1020279-2022-01357
• Device Sequence Number: 2148548
• Product Code: OLO
• UDI-Device Identifier: 03596010460431
• UDI-Public: 03596010460431
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2022
• 2 Devices were Involved in the Event: 1 2

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: 71440209
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/08/2022; 04/20/2022; 04/20/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/12/2022; 04/21/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71440209/15GM11047 - GII SLT 3 MOD TIB CUTBLCK LT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown