MAUDE Adverse Event Report: DEPUY SPINE INC QUICK CONNECT SI POLYDRIVER; SCREWDRIVER

Model Number	698340694
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: a review of the receiving inspection (ri) for quick connect si polydriver was conducted identifying that lot number gm51509mt was released in a single batch.Batch1: lot was released on march 9, 2018 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 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.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 that on (b)(6) 2020, the surgeon was inserting an expedium polyaxial screw in the posterior thoracic region of the spine when he noticed the tip of the screwdriver was stripped and it was becoming increasingly difficult to properly turn the screwdriver and insert the screw.Upon closer observation, the hex end of the screw-driver was becoming stripped.The lines on the hex end tip of the screwdriver were bent and not uniform.The instrument in question is a custom short quick connect polyaxial screwdriver.The procedure was successfully completed using another quick connect screwdriver.There was no surgical delay.There was no patient consequence.Concomitant device reported: expedium polyaxial screws (part# unknown, lot# unknown, quantity unknown) this report is for one (1) quick connect si polydriver.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the distal tip of the modified t20 shaft component was stripped.No other issues were identified with the returned components of the device.The distal tip of the device was measured and was within the specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The device received was stripped; hence confirming the allegation.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: QUICK CONNECT SI POLYDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10495080
• Report Number: 1526439-2020-01607
• Device Sequence Number: 2567720
• Product Code: HXX
• UDI-Device Identifier: 10705034466743
• UDI-Public: (01)10705034466743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 698340694
• Device Catalogue Number: 698340694
• Device Lot Number: GM51509MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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: UNKNOWN SCREWS; UNKNOWN SCREWS.
• Patient Age: 18 YR