MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT PERC TAN/FAN DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) ref# (b)(4).It was reported that, during a trigen mrta tan surgery, the sureshot perc tan/fan drill guide probe was not removed before drilling the lag screw.It was found while drilling.Then the probe was removed.However, the tip of the probe broke into 2 pieces inside the nail.One piece was inside the nail and the other was left inside the femoral head.The procedure was completed with the same device.There was one hour of surgical delay.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the information provided the clinical root cause of the report breakage is the result of a user vs procedural variance as the case details state that the ¿probe was not removed before drilling the lag screw.¿ the sureshot drill guide probe is an externally communicating device and is not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the retained foreign body and extended surgical time could not be definitively determined.Although unlikely, the potential for possible corrosion, local irritation/discomfort, and/or migration of the retained fragment could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 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 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: SURESHOT PERC TAN/FAN DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11627510
• Report Number: 1020279-2021-02777
• Device Sequence Number: 19653240
• Product Code: OLO
• UDI-Device Identifier: 03596010648150
• UDI-Public: 03596010648150
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100107
• 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): 05/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71692815
• Device Catalogue Number: 71692815
• Device Lot Number: 20DK00109
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/13/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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: Hospitalization; Other; Required Intervention