MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS PIN AND DRILL SET; PLATE, FIXATION, BONE

Model Number	114968
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, a genesis pin and drill set broke when the surgeon was drilling the holes, prior to pinning to secure and finish the tibial ream.The broken part could not be removed and remained in the patient's tibia.Surgery was finished without further usage of the drill.No significant delays reported.Current health status of patient is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that the device is broken.The clinical/medical investigation concluded that, this case reports the breakage of the genesis pin and drill set, intra-operatively the broken part was left inside of patients tibial.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported breakage could not be determined.The genesis pin and drill sets are comprised of ss, and they are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.Since the broken part was retained the patient¿s tibial micro-motion and/or migration is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.Based on the information provided, the surgery was completed without further usage of the drill with an approximately 30-minute surgical delay.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded due to the lack of information.Should any additional medical information be provided, this case would be re-assessed.Therefore, no further clinical/medical investigation is warranted at this time.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 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 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, therefore damage from prolonged use, misuse or rough handling are likely probable causes 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 incident could be corroborated as the picture reveal that the device is broken.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: GENESIS PIN AND DRILL SET
• Common Device Name: PLATE, FIXATION, BONE
• 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: 15136635
• Report Number: 1020279-2022-03554
• Device Sequence Number: 20150697
• Product Code: HRS
• UDI-Device Identifier: 03596010051332
• UDI-Public: 03596010051332
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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
• Report Date (Section B): 09/06/2022

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: 114968
• Device Catalogue Number: 114968
• Device Lot Number: 20GM18497
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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: Other
• Patient Sex: Unknown