MAUDE Adverse Event Report: DEPUY SPINE INC DI QUICK CONNECT POLYAXIAL SCREWDRIVER; SCREWDRIVERS

Model Number	279722400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during a posterior spinal fusion (psf) procedure to treat a lumbar spinal stenosis while the screw (179722945) was being inserted into the sturdy bone, the tip of the screwdriver (2797224009) broke.The fragmented tip and the screw were removed and the procedure was completed with replacements with less than a 30-minute surgical delay.Concomitant device: exp di poly screw 9x45mm ti (part#: 179722945, lot#: rl267374, quantity: 1).This report is for one (1) di quick connect polyaxial screwdriver.This is report 1 of 1 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.H3, h4, h6: a review of the receiving inspection (ri) for xpdm quick-con di poly scwdrvr was conducted identifying that lot number mi60389 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 17 jul 2017 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.Visual inspection: the xpdm quick-con di poly scwdrvr (part # 279722400, lot # mi60389) was received at customer quality (cq).The distal tip of the device has completely broken off.No fragments were returned.The anodization of the screw driver¿s color ring has worn off.No other defects were identified.The received condition was consistent with the complaint condition thus the complaint is confirmed.Device failure/defect identified? yes; distal tip was broken and color ring was discolored.Dimensional inspection: since distal tip has completely broken off, shaft diameter just proximal to breakage was measured.Measured dimensions: shaft diameter = conforming.Conclusion: the overall complaint was confirmed for the received xpdm quick-con di poly scwdrvr (part # 279722400, lot # mi60389) as the distal tip of the device has completely broken off.There was no evidence of the threaded tip after the breakage.However no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: DI QUICK CONNECT POLYAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9882684
• Report Number: 1526439-2020-00768
• Device Sequence Number: 2750092
• Product Code: HXX
• UDI-Device Identifier: 10705034199344
• UDI-Public: (01)10705034199344
• 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
• Report Date (Section B): 02/28/2020

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: 279722400
• Device Catalogue Number: 279722400
• Device Lot Number: MI60389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: EXP DI POLY SCREW 9X45MM TI