MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CEMENT DRILL 4.5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71369045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr 2 stage revision (1 stage) procedure, while surgeon was in the process of removing cement from the femoral canal with the cement drill 4.5mm from the renovation set, the drill tip snapped off.This caused the device became lodged in the femoral canal.An attempt was made to retrieve the drill bit initially, the fluoroscopy showed the drill tip wedged between a revision knee stem and the femoral cortex.Surgeon commented that this adverse event would be addressed during the revision of the knee prosthesis by removing the broken drill tip.Surgery was resumed, with more than an one hour delay.It is unknown how surgery was finished.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
B5 (event description updated), d9 (device not available for evaluation).
Event or Problem Description
It was reported that, during the first stage of a two-stage revision surgery of competitor devices, the tip of the cement drill 4.5mm snapped off while removing cement from the femoral canal and became lodged in the femoral canal.An attempt was made to retrieve the drill bit initially; the fluoroscopy showed the drill tip wedged between a revision knee stem and the femoral cortex.The surgeon commented that this adverse event would be addressed during the revision of the knee prosthesis by removing the broken drill tip.Surgery was resumed, with more than one hour delay.It is unknown how surgery was finished.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation but the reported event could be confirmed with the conclusions of the clinical/medical review using the fluoroscopic image.The clinical/medical investigation concluded that, based on the limited information provided, there were no clinical factors presented which would have contributed to the event.The provided fluoroscopic image was reviewed and supports the reported ¿drill tip wedged between the revision knee stem and the femoral cortex.¿ it was noted the removal of the drill bit would be addressed during the revision.It is unknown if this noted ¿revision¿ is already planned or now required due to this drill tip being left behind.No additional information was provided.The material composition is 17-4 ph 55t/ astm f899.The drill bit is not intended for long term internal exposure and long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 reason to suspect that the product failed to meet any product 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 of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could be corroborated, as the device broke as shown in the fluoroscopic image and the issue would be addressed during the revision of the knee prosthesis by removing the broken drill tip, besides the surgery had a delay of more than one hour.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: CEMENT DRILL 4.5MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 15316108
• Report Number: 1020279-2022-03872
• Device Sequence Number: 5505490
• Product Code: KTT
• UDI-Device Identifier: 03596010437617
• UDI-Public: 03596010437617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2022

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: 71369045
• Device Catalogue Number: 71369045
• Device Lot Number: 05AM01631
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 10/04/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/05/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown