MAUDE Adverse Event Report: DEPUY SPINE INC MMSI DRIVER SHAFT FOR RED SCRW

Model Number	279732100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the device was received, the investigation is in progress, 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported during a tlif (transforaminal lumbar interbody fusion) treating asd (adult spinal deformity) on (b)(6) 2020, the screw was not able to be connected to a screwdriver.The procedure was completed without surgical delay.Patient is noted as stable concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for (1) mmsi driver shaft for red screw.This complaint involve two (2) devices.This is report 1 of 2 for (b)(4).
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.Visual inspection: the mmsi driver shaft for red scrw (p/n 279732100 & lot # r0304) at uscq.Upon visual inspection it was noticed that the distal end was broken and the broken part was lodged inside the shank of si polyaxl ext tab 7 x 45mm.No other issues were identified on the device.Dimensional inspection: the shaft diameter adjacent to the breakage was measured.Measured diameter: 3.77 mm, specified diameter: 3.77 +/-0.33 mm, confirmed.Document/ specification review: no issues.Complaint confirmed? yes.Conclusion: the complaint is confirmed for mmsi driver shaft for red scrw (p/n 279732100 & lot # r0304).A definitive root cause could not be determined with the returned device.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: a review of the receiving inspection (ri) for mmsi driver shaft for red scrw was conducted identifying that lot number r0304 was released in a single batch.Batch1: lot qty of 164 units were released on 11mar2004 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.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: MMSI DRIVER SHAFT FOR RED SCRW
• Common Device Name: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10426111
• Report Number: 1526439-2020-01490
• Device Sequence Number: 14104775
• Product Code: HWR
• UDI-Device Identifier: 10705034200200
• UDI-Public: 10705034200200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279732100
• Device Catalogue Number: 279732100
• Device Lot Number: R0304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 09/01/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/01/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SI POLYAXL EXT TAB 7 X 45MM; SI POLYAXL EXT TAB 7 X 45MM