MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE SET SCREW WRENCH (HEX)

Model Number	205050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Awaiting sample: a follow up report will be filed upon completion of the investigation.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 during the set up of instruments and prior to patient entering the room for a lumbar decompression and fusion surgery, the scrub nurse noted that the tip of the instrument, the screw driver tip was missing and completely broken off.Completed with same/like product.
Additional Manufacturer Narrative
The is set screw hexdriver was returned for evaluation.Visual inspection revealed that the fracture was located at the driver¿s distal tip.Optical imaging found evidence that suggests that the driver underwent a static overload failure.The supplier is unable to provide a device history record at this point.If a device history record becomes available that identifies any issues during the manufacturing or release of this product that could have contributed to the reported problem, a follow up medwatch will be filed.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively identified however fracture analysis suggests that the driver underwent a static overload.It is possible for this type of failure to occur during instrument reprocessing.As no systemic trends have been observed or material defects identified, this complaint file will be closed with no further action required unless additional information becomes available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SET SCREW WRENCH (HEX)
• Common Device Name: WRENCH
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6764218
• Report Number: 1526439-2017-10627
• Device Sequence Number: 1411892
• Product Code: HXC
• UDI-Device Identifier: 10705034001449
• UDI-Public: (01)10705034001449
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: Physician
• Device Model Number: 205050
• Device Catalogue Number: 205050
• Device Lot Number: 0701V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 09/11/2017
• Patient Sequence Number: 1