MAUDE Adverse Event Report: DEPUY SPINE INC MOD THREADED GRAFT PUSHER ASSY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	698342220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), unknown.The 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
Plastic component of this item broken during excessive force as doctor was driving bone through the funnel.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual inspection on the returned device found the threaded graft pusher handle was broken.Broken part was not returned.Overall device was in fair condition.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.Potential root cause can be that handle experienced unintended excessive force during procedure.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: MOD THREADED GRAFT PUSHER ASSY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8730464
• Report Number: 1526439-2019-51787
• Device Sequence Number: 1729195
• Product Code: LXH
• UDI-Device Identifier: 10705034486444
• UDI-Public: (01)10705034486444
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 698342220
• Device Catalogue Number: 698342220
• Device Lot Number: GM49757MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1