MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE DI FINAL TIGHTENER; DRIVER, PROSTHESIS

Model Number	279722600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Lot unknown.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product discarded.
Event or Problem Description
Item 1: x 25 final tightener 2797.12.600 is burred and needs to be replaced - surgeon request.The second x 25 final tightener was then used.No time was lost.Item 2: di castle innie tightener 2797.22.600 there are x 4 points at the end of the instrument and it was noted at the end of the operation that x 1 tip was missing.The surgeon could not see the tip in the operating field and was happy to continue.No time was lost.No reported ae to patient.No delay to procedure.'product discarded' has been selected for product status in this instance as there is no appropriate status available to represent the following local process: instrument will be sent to local engineering for assessment of wear and tear.If 'wear and tear' is assigned, a copy of the local assessment will be provided to the manufacturer for their record and case closure.In the case wear and tear cannot be assigned by the engineer, the product will be returned to the manufacturer as a 'product complaint' for investigation.

• Brand Name: DI FINAL TIGHTENER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6801797
• Report Number: 1526439-2017-10669
• Device Sequence Number: 10982400
• Product Code: HWR
• UDI-Device Identifier: 10705034199399
• UDI-Public: (01)10705034199399
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/27/2017

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: 279722600
• Device Catalogue Number: 279722600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/17/2017
• Patient Sequence Number: 1