MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT HEXDRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the lag screw length gauge ((b)(4)) and the sureshot hexdriver ((b)(4)) were noticed broken.The devices broke outside the patient.No delay or injury reported.The procedure was finished using a smith and nephew backup device.
Additional Manufacturer Narrative
The devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices did confirm they were broken and appear to be excessively worn.The manufactured date for this device is 2018.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.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.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.Case-2021-00040944-2.

• Brand Name: SURESHOT HEXDRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11408835
• Report Number: 1020279-2021-01798
• Device Sequence Number: 14338790
• Product Code: OLO
• UDI-Device Identifier: 03596010648235
• UDI-Public: 03596010648235
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 71692809
• Device Catalogue Number: 71692809
• Device Lot Number: 18KVE0003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1