MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT HUMERAL DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71691152
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during and internal fixation surgery, the sureshot humeral drill guide probe did not correctly show the point for distal blocking of the humeral rod.Surgery was resumed, after a non-significant delay, with a change in surgical technique.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Additional information added: b2.Corrected data: b1, b5, h1, h6(health effect - clinical code).
Event or Problem Description
It was reported that, during and internal fixation surgery, the sureshot humeral drill guide probe did not correctly show the point for distal blocking of the humeral rod.Surgery was resumed, after a non-significant delay, with a change in surgical technique by blocking of the distal screws by free hand method using an image intensifier tube, an additional bone hole was drilled.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the functional failure mode.The clinical/medical investigation concluded that, as of the date of this medical investigation, no clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Two undated, unlabeled photos of a probe and cord were provided however, they don¿t aid in determining a root cause of the reported failure.Based on a review of the information provided, the surgeon was able to complete the procedure with a non-significant delay with a change in the surgical technique.According to the report, the surgeon blocked the distal screws by free hand method using an image intensifier tube, in an additional bone hole that was drilled.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, since no harm has been alleged to this patient, no further clinical medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Corrected data: h3, h6 (health effect - clinical code).

• Brand Name: SURESHOT HUMERAL DRILL GUIDE PROBE
• 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: 15242434
• Report Number: 1020279-2022-03695
• Device Sequence Number: 17715382
• Product Code: OLO
• UDI-Device Identifier: 00885556195284
• UDI-Public: 00885556195284
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K110240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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 Expiration Date: 04/18/2026
• Device Model Number: 71691152
• Device Catalogue Number: 71691152
• Device Lot Number: 16DM14550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 09/13/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 08/25/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown