MAUDE Adverse Event Report: DEPUY SYNTHES SPINE OC 4.5 UNIVERSAL SCREWDRIVER

Model Number	288312000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up will be submitted 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
Reported by commercial coordinator in (b)(6).We have also product complaints in (b)(4) depuy (orthokit/loaner site) for 2017 year.Devices quarantined due to breakages, functional tests failures.In all cases no data available if any injures or adverse events.No information about surgery, delays, patient related data.
Additional Manufacturer Narrative
Visual examination of the returned device found the tip of the driver was missing entirely.The tip of the driver is welded into place.This weld appears to have failed, resulting in driver tip falling out.The driver tip was not returned with the device.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.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the universal screwdriver tip breaking off cannot be determined from the samples and the information provided.A potential root cause may be the weld holding the driver tip in place failing as a result of unexpectedly high forces placed on the tip during use and several years of wear.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: OC 4.5 UNIVERSAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6711738
• Report Number: 1526439-2017-10578
• Device Sequence Number: 19275409
• Product Code: HXX
• UDI-Device Identifier: 10705034221779
• UDI-Public: (01)10705034221779
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 288312000
• Device Catalogue Number: 288312000
• Device Lot Number: 0810V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1