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

Model Number	279722550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.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.Device not yet returned for evaluation.
Event or Problem Description
On tightening of the di nut, the tip (teeth) of the castle tightener snapped off.This happened also on the second after i had reminded the surgeon that this tightener didn¿t torque off.
Additional Manufacturer Narrative
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.A trend analysis was conducted.No emerging trends were found requiring further actions.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
Device was returned for evaluation after initial closure of complaint.Two of the four castle nut tabs were broken off.Optical imaging suggests a static overload failure.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the castle tighteners¿ tips breaking could not be determined from the samples and the information provided.The results of fracture analysis have determined that a potential root cause may be static overload failures.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: DI INTERMEDIATE TIGHTENER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6741650
• Report Number: 1526439-2017-10611
• Device Sequence Number: 1267553
• Product Code: HWR
• UDI-Device Identifier: 10705034199382
• UDI-Public: (01)10705034199382
• 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,Followup
• Report Date (Section B): 07/03/2017

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: 279722550
• Device Catalogue Number: 279722550
• Device Lot Number: NW104546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/24/2017; 09/28/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/29/2017; 10/03/2017
• Patient Sequence Number: 1