MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631432
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during internal fixation surgery, there was a lot of resistance in the bone and the meta-tan lag screw drill failed to advance.The sales rep advised surgeon to stop as the tips of the drill flared out on the x-ray.When the surgeon tried to reverse the drill, it snapped off in the patient's femur neck.There was no way to continue this step or remove the drill, for which they proceeded to complete the operation without inserting the lag screw.Even though the surgeon attempted additional fixation with a std locking mode, the fixation did not hold and the patient was taken for a revision with new instrumentation 3 days later.The broken pieces cannot be retrieved and are still in the patient's femur neck.Patient's outcome is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H11- corrected data.B5- describe event or problem.
Event or Problem Description
It was reported that, during internal fixation surgery, there was a lot of resistance in the bone and the meta-tan lag screw drill failed to advance.The sales rep advised surgeon to stop as the tips of the drill flared out on the x-ray.When the surgeon tried to reverse the drill, it snapped off in the patient's femur neck.There was no way to continue this step or remove the drill, for which they proceeded to complete the operation without inserting the lag screw.Even though the surgeon attempted additional fixation with a std locking mode, the fixation did not hold and the patient was taken for a revision with new instrumentation 3 days later.During this procedure, the std locking screw (which was backing out) was removed and screws were placed where the drill broke off by exchanging the nail to a shorter one.The broken pieces could not be retrieved and are still in the patient's femur neck.This was needed to place the nail deeper for the recon screws to fit underneath where the drill broke off.Patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, with the information provided, the definitive clinical root cause of the broken meta-tan lag drill tip cannot be confirmed.Although a procedural variance cannot be ruled out as a contributing factor.The retained meta-tan lag screw drill tip is comprised of 17.4 ss an externally communicating device that is neither manufactured nor intended for implantation; therefore, no long-term exposure with skin or tissue data is available.The drill tip was retained in the neck of the femur, therefore, micro-motion/and or migration is unlikely.However, we cannot make conclusions on the impact of the retained non-implantable foreign body.The impact to the patient beyond the retained drill tip, the screw backing out and the revision cannot be determined since the patient¿s outcome is unknown.Therefore, no further clinical/medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the surgical technique for trigen meta-tan revealed that it is the responsibility of treating physicians to determine and utilize the appropriate products and techniques, according to their own clinical judgment, for each of their patients.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: META-TAN LAG SCREW DRILL
• 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: 18510513
• Report Number: 1020279-2024-00101
• Device Sequence Number: 6991639
• Product Code: HSB
• UDI-Device Identifier: 00885556158395
• UDI-Public: 00885556158395
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2024

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 Catalogue Number: 71631432
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 02/22/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 01/17/2024; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female