MAUDE Adverse Event Report: DEPUY SPINE INC MOD T20 DRIVER SHORT; DRIVER, PROSTHESIS

Model Number	698337505
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for a surgery.During the surgery, the tip of the t20 driver broke off in the shaft of the screw and could not be removed.The surgery was completed without surgical delay.There was no patient consequence.Concomitant device reported.Di polyaxl screw 8 x 65mm (part # 179722865, lot # unknown, qty 2), si polyaxl screw 7 x 40mm (part # 179722000, lot # unknown, qty 2), exp dual-inner set screw (part # 179793050, lot # unknown, qty 2), ti fixed lat connector 50mm (part # 179712740, lot # unknown, qty 3), si polyaxl screw 7 x 35mm (part # 179712735, lot # unknown, qty 1).This complaint involves two (2) devices.This report is for (1) mod t20 driver short.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed based on the images provided.Upon inspecting the photos provided, the tip of the device was noted to be broken and the complaint condition can be confirmed.Tip damage is believed to be related to wear from normal prolonged use.The root cause of this issue cannot be confirmed based on the provided photo.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed for the mod t20 driver short (sri product code: iau0242 / 698337505, lot: enz151118).The reported complaint condition of the broken fragment being embedded cannot be confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot.Sri product code: iau0242.Lot: enz151118.The dhr was performed by sri australia team.Per the lot number recorded the instrument was first released in 2018.A total of (b)(6) instruments have been manufactured to date with this product code, and was first released in 2010.The product was manufactured as per the specification and no non conformance can be found.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOD T20 DRIVER SHORT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13014252
• Report Number: 1526439-2021-02565
• Device Sequence Number: 1893749
• Product Code: HWR
• UDI-Device Identifier: 10705034377261
• UDI-Public: 10705034377261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 698337505
• Device Catalogue Number: 698337505
• Device Lot Number: ENZ151118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/22/2021; 01/25/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/24/2022; 01/25/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DI POLYAXL SCREW 8 X 65MM; EXP DUAL-INNER SETSCREW; SI POLYAXL SCREW 7 X 35MM; SI POLYAXL SCREW 7 X 40MM; TI FIXED LAT CONNECTOR 50MM; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female