MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SEMIEXTENDED DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71654524
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a trauma surgery for a mid-shaft tibia fracture, the top of a semiextended drill guide was noticed to be loose, and eventually, it came apart.The procedure was resumed, after a delay greater than 30 minutes, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the device fractured into two pieces.Both pieces were returned.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Additional information: d9- date device returned to manufacturer h11 ¿ corrected data.B1- product problem.B2- outcomes attributed to adverse event.B5- describe event or problem.D3- manufacturer: please note that the email address (b)(6) was removed, as it does not correspond to the manufacturing site contact.
Event or Problem Description
It was reported that, during trauma surgery for a mid-shaft tibia fracture, once the tibial nail was loaded on one (1) semiextended drill guide and fully seated in the tibia, it was noticed that the top guide was loose.The loose part eventually came apart and the meta-nail anterior drop could not be attached for accurately targeting the proximal screws in the tibial nail.The procedure was resumed, after a delay greater than 30 minutes, with a s+n back-up device.Patient was not injured as consequence of this problem.
Event or Problem Description
It was reported that, during trauma surgery for a mid-shaft tibia fracture, once the tibial nail was loaded on one (1) semiextended drill guide and fully seated in the tibia, it was noticed that the top guide was loose.The loose part eventually came apart and the meta-nail anterior drop could not be attached for accurately targeting the proximal screws in the tibial nail.The procedure was resumed, after a delay greater than 30 minutes, with a s+n back-up device.Patient was not injured as consequence of this problem.

• Brand Name: SEMIEXTENDED DRILL GUIDE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 17108828
• Report Number: 1020279-2023-01274
• Device Sequence Number: 6273494
• Product Code: HSB
• UDI-Device Identifier: 03596010644596
• UDI-Public: 03596010644596
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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 Model Number: 71654524
• Device Catalogue Number: E0006728-3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2023
• Supplement Date Received by Manufacturer: 06/04/2023; 07/20/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2009
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown