MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP DI FAR CASTLE TIGHTENER; DRIVER, PROSTHESIS

Catalog Number	279722870
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 a ratchet and torque limiter broke intraoperatively.In addition the tip of the screwdriver deformed.Ratchet: 286710490 ¿ when screwing broken the screw screwdriver: 279734000 ¿ through frequent use turn around the neck of the screw (the tip of the screwdriver deformed.) torque limiter: 279722870 ¿ during the final tightening of the external thread of the di innies, one of the 3 attachment points is broken off.No patient harm nor surgery prolongation reported.Procedure finished successfully with this complaint involves 3 parts.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual inspection showed that the distal tip of the instrument was fractured.Microscopic evaluation of the axial surface of the tightener shows two (2) teeth completely broken off.The evaluation shows a third tooth that experienced plastic deformation consistent with a torsional overload 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.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause cannot be determined.However, based on device evaluation, a potential root cause may be due to wear and tear or the device 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 DI FAR CASTLE TIGHTENER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7109602
• Report Number: 1526439-2017-50065
• Device Sequence Number: 85693
• Product Code: HWR
• UDI-Device Identifier: 10705034199436
• UDI-Public: 10705034199436
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: Health Professional
• Device Catalogue Number: 279722870
• Device Lot Number: GB44104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1