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

Model Number	71691152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while drilling the distal screw using a sureshot, it was found the hole was out of alignment.They believe guide probe was set at "20" but it actually wasn't.It was loosed.Even when they tried to set "20" again, it did not work.Delay form, (0-30) minutes reported.Backup device available.No injury or impact to patient reported.
Additional Manufacturer Narrative
It was reported that during surgery, while drilling the distal screw using a sureshot, it was found the the hole was out of alignment.The associated sureshot humeral drill guide probe, used in treatment, was returned and evaluated.A visual inspection of the returned device shows the rod is bent.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A functional test noted no issue with the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.The device was manufactured in 2018.The probe is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Damage from repeated use can occur and some causes for the malfunction would include metal interference, probe not inserted correctly or damaged probe.The sureshot device user manual is available, identifying pre-operative requirements for use and troubleshooting suggestions if needed.Based on this investigation, the need for corrective action is not indicated at this time.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: SURESHOT HUMERAL DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9443678
• Report Number: 1020279-2019-04343
• Device Sequence Number: 19387970
• Product Code: OLO
• UDI-Device Identifier: 00885556195284
• UDI-Public: 00885556195284
• Combination Product (Y/N): N
• PMA/510(K) Number: K110240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 71691152
• Device Catalogue Number: 71691152
• Device Lot Number: 18GK00016
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1