MAUDE Adverse Event Report: DEPUY SPINE INC POLY DRIVER, 10MM; DRIVER, PROSTHESIS

Model Number	286760010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the x-tab screwdriver tip broke off during mis tlif procedure done by dr (b)(6).X-ray and microscope was used by surgeon to find the broken metal parts but it could not be found.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection at the microscopic level revealed that the fracture was located at the driver¿s distal tip.The device features two vertical fractures at the distal tip which is the thinnest section of the device.The broken part of the driver¿s tip was not returned.Based on these observations, it is believed that the driver¿s tip experienced high amount of stresses during impaction to result in it fracturing.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.The root cause of the device breaking cannot be determined from the sample and the information provided.A potential root cause may be high forces inadvertently placed on the driver¿s tip during impaction, exerting enough force to result in the fracture.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, 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: POLY DRIVER, 10MM
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8550939
• Report Number: 1526439-2019-51561
• Device Sequence Number: 2443968
• Product Code: HWR
• UDI-Device Identifier: 10705034214887
• UDI-Public: (01)10705034214887
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2019

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 Model Number: 286760010
• Device Catalogue Number: 286760010
• Device Lot Number: MI28295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1