MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 CLOSED POLY DRIVER; DRIVER, PROSTHESIS

Model Number	279718101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that the procedure was a revision surgery with previous expedium 6.35 s2 alar iliac screws in place.We took out a 9x100 screw and the doctor decided to upsize to a 10x100 closed head exp 6.35 screw.The doctor placed the screw initially without problem, but later decided he wanted to advance the screw a couple more rotations.During this step, we broke 3 different exp 6.35 screwdrivers, 2 of the t27 snapped off and the other driver had the connection threads snap off.The surgeon decided to leave the screw as is after the 3rd driver broke.Patient consequence?: no.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.
Additional Manufacturer Narrative
(b)(4).Corrected data.Additional information.Device was not returned for evaluation.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.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).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.Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver tip was not returned for analysis.Fracture analysis was performed on the device.The fracture analysis report 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 of the fractured tip.This suggests that the fractured tip 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 instrument¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the fractured tip 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 6.35 CLOSED POLY DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7873046
• Report Number: 1526439-2018-50881
• Device Sequence Number: 11274993
• Product Code: HWR
• UDI-Device Identifier: 10705034301396
• UDI-Public: (01)10705034301396
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2018

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: 279718101
• Device Catalogue Number: 279718101
• Device Lot Number: GM3840801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 09/24/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/18/2018; 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1