MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 5.5 CLOSED POLY DRIVER; SCREWDRIVER

Model Number	279718100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 screwdriver tip broke in the screw interface.When the surgeon tried to final tighten set screw on the rod, the set screw stripped and broke.We had to saw the head off the screw and then use a universal removal set and a reverse threaded driver to get the illiac screw out.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: one (1) exp 5.5 closed poly driver (product code: 279718100, lot # gm4275401) was returned for evaluation.Visual examination of the returned device found the distal tip of driver was fractured.Device was then sent for fracture analysis.Optical imaging of the fractured surface reveals plastic deformation at the hex-lobes and torsional shear markings following a circular pattern.The plastic deformation at the hex-lobes indicates a torsional overload.This suggests the driver underwent a quasi-static overload torsional shear failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the tip of the expedium t20 closed polyaxial driver being broken cannot be determined.However, fracture analysis suggests that driver underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXP 5.5 CLOSED POLY DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7452114
• Report Number: 1526439-2018-50397
• Device Sequence Number: 1607791
• Product Code: HXX
• UDI-Device Identifier: 10705034301389
• UDI-Public: (01)10705034301389
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 279718100
• Device Catalogue Number: 279718100
• Device Lot Number: GM4275401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1