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

Model Number	71631448
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after surgery, it was noticed the meta-tan comp screw starter drill had broken off.An imaging confirmed the piece remains inside the patient's body.Procedure had been completed, without any delay, using the same device.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the tip, rendering the device inoperative.The fractured components were not returned.The clinical/medical evaluation concluded that this case reports a tip breakage of the meta-tan comp screw starter drill; however, the broken tip was not recovered from inside of the patient.According to the report, an unprovided imaging confirmed the broken tip remains inside of the patient¿s body.Per the report, the surgeon does not plan to remove the retained piece.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the clinical root cause of the reported meta-tan comp screw starter drill tip breakage could not be determined.The meta-tan comp screw started drill tips are comprised of 17.4 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.Therefore, patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.Based on the information provided, the procedure was completed, without any delay, using the same device.Since it was reported the current health status of patient is unknown.No further medical assessment can be rendered at this time.Should any additional medical information be provided, this case would be re-assessed.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 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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Damage from misuse or rough handling are likely probable causes of the reported event.This is a single-use device and should be discarded after its first use.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.

• Brand Name: META-TAN COMP SCREW STARTER 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: 13935443
• Report Number: 1020279-2022-01383
• Device Sequence Number: 17144769
• Product Code: HSB
• UDI-Device Identifier: 00885556158319
• UDI-Public: 00885556158319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• 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
• Report Date (Section B): 05/02/2022

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 Expiration Date: 07/09/2026
• Device Model Number: 71631448
• Device Catalogue Number: 71631448
• Device Lot Number: 15MNG0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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: Required Intervention
• Patient Sex: Unknown