MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM COUNTER TORQUE DRIVER 5.5 X20; DRIVER, PROSTHESIS

Model Number	279729524
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that on (b)(6) 2020, during an unknown procedure the tip of the two (2) screwdrivers was rounding off while removal of the bolt.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.Concomitant medical products: iexp ti fixed blt 7 x 40mm (part# 175422740, lot# unknown, quantity unknown).This report is for one (1) expedium spine system counter torque driver 5.5 x20.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d10 h3, h4, h6: a review of the receiving inspection (ri) for expedium offset x20 ctd was conducted identifying that lot number gb43377 was released in a single batch on september 19, 2012 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.H3, h6: a product investigation was completed: upon visual inspection, the distal tip of the device was observed to be stripped.The observed condition was consistent as an end of life indicator for the device.This was consistent with the reported complaint condition, thus confirming the complaint.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.The complaint was confirmed during investigation.It is determined that the reusable instrument device is worn from repeated use and servicing.During investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H11: corrected data: e1 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: EXPEDIUM SPINE SYSTEM COUNTER TORQUE DRIVER 5.5 X20
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10642978
• Report Number: 1526439-2020-01893
• Device Sequence Number: 11675053
• Product Code: HWR
• UDI-Device Identifier: 10705034358680
• UDI-Public: (01)10705034358680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 279729524
• Device Catalogue Number: 279729524
• Device Lot Number: GB43377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXPEDIUM OFFSET X20 CTD; IEXP TI FIXED BLT 7 X 40MM; EXPEDIUM OFFSET X20 CTD.; IEXP TI FIXED BLT 7 X 40MM.
• Patient Age: 47 YR