MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SS META SEMIEXTENDED DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692803
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the stainless steel meta semiextended drill guide probe did not work correctly.The procedure was finished with a change in surgical technique, using the radiolucent drill.There was a surgical delay of 10 minutes due to this issue.No injury to the patient was reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure.The device exhibits signs of normal wear and use.A function evaluation was conducted with a sureshot targeter and interface unit.The ss meta semiextended drill guide probe function as intended.The stated failure could not be confirmed.A medical investigation was conducted and confirms per the complaint details, it was reported stainless steel meta semi-extended drill guide probe did not work correctly during use outside of the patient.Additionally, it was reported no relevant clinical information would be provided.Based on the limited information provided, the procedure was completed with a change in surgical technique, using the radiolucent drill with a surgical delay of 10 minutes due to this issue.Since there were no injury to the patient was reported; no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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.Possible probable cause could include but not limited the user error.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SS META SEMIEXTENDED DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11627519
• Report Number: 1020279-2021-02778
• Device Sequence Number: 14272938
• Product Code: OLO
• UDI-Device Identifier: 03596010648136
• UDI-Public: 03596010648136
• 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): 09/28/2021

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: 71692803
• Device Catalogue Number: 71692803
• Device Lot Number: 19GK00091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71692810, LOT: 18KNG0145
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention