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

Catalog Number	71692814
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trauma surgery, the meta-nail tibial was used with sureshot and insertion of the probe attempted after proximal locking.After the probe would not progress with force, the issue was identified and proximal screws retracted.Distal locking was done using sureshot and worked as expected but when removing the probe, the distal end remained within the nail in the patient and may come in contact with body fluids given that not all holes have been filled.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation conducted and no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.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 META STANDARD DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7513460
• Report Number: 1020279-2018-00931
• Device Sequence Number: 16776095
• Product Code: OLO
• UDI-Device Identifier: 03596010648143
• UDI-Public: 03596010648143
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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 Catalogue Number: 71692814
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2018
• Supplement Date Received by Manufacturer: 04/29/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 07/05/2018
• 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: Other