MAUDE Adverse Event Report: DEPUY SPINE INC MOD QK CONNECT T20 DRIVER ASSY; SCREWDRIVERS

Model Number	698343320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device returned.510k unknown device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history record.Device history lot a review of the receiving inspection (ri) for surgeon request team / serial/label lot number (b)(4) was conducted identifying that lot number wa22483 was released in a single batch.Batch1: lot qty of 1 units were released on 03 jan 2019 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 history batch null, device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Investigation summary background: it was reported on (b)(6) 2020, during an unknown procedure which stated of a broken stripped screwdriver.The surgeon was known for 7-10 minutes for removing the broken distal tip out of the ria implant system using expedium 5.5 implant, taking the implant screws.There was a surgical delay of approximately seven to ten (7-10) minutes.There were fragments generated and easily removed.Patient status is unknown.The procedure was successfully completed.Concomitant device reported: expedium 5.5 screws (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the mod qk connect t20 driver assy (part #: 698343320, lot #: wa22483) was received at us cq.The distal tip of the device is broken as the drive feature has completely broken off.The condition of stripped can not be confirmed since the driver tip was not returned for investigation.The received condition of broken tip is consistent with the complaint condition thus the overall complaint is confirmed.Device failure/defect identified? yes; distal tip of the device is broken.Dimensional inspection: distal tip was completely broken so shaft diameter just proximal to the breakage was measured.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).103448748, mod qk connect t20 driver assy rev b.103487433, mod t20 driver shaft rev a.Manufacturing record evaluation: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the received mod qk connect t20 driver assy (part #: 698343320, lot #: wa22483) as the distal tip of the device was broken.The drive feature was completely broken off.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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
It was reported on (b)(6) 2020, during an unknown procedure which stated of a broken stripped screwdriver.The surgeon was known for 7-10 minutes for removing the broken distal tip out of the ria implant system using expedium 5.5 implant, taking the implant screws.There was a surgical delay of approximately seven to ten (7-10) minutes.There were fragments generated and easily removed.Patient status is unknown.The procedure was successfully completed.Concomitant device reported: expedium 5.5 screws (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves one (1) device.This report is 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.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 QK CONNECT T20 DRIVER ASSY
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9832822
• Report Number: 1526439-2020-00717
• Device Sequence Number: 10948461
• Product Code: HXX
• UDI-Device Identifier: 10705034497853
• UDI-Public: (01)10705034497853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 698343320
• Device Catalogue Number: 698343320
• Device Lot Number: WA22483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS
• Patient Age: 76 YR