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

Catalog Number	71692815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new probe was broken and can't be used, resulting in the procedure delay greater than thirty minutes.
Additional Manufacturer Narrative
The affected sureshot percutaneous tan/fan drill guide probe was returned and evaluated.A visual inspection of the product confirms the stated failure.The probe is fractured at the middle section of the part, rendering the device to be defective.The device was manufactured in 2018.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: SURESHOT PERC TAN/FAN DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8061390
• Report Number: 1020279-2018-02423
• Device Sequence Number: 11259526
• Product Code: OLO
• UDI-Device Identifier: 03596010648150
• UDI-Public: 03596010648150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/16/2019

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 Catalogue Number: 71692815
• Device Lot Number: 18AK00049
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1