MAUDE Adverse Event Report: DEPUY SPINE INC XPDM DI INTERMEDT CASTLE TIGHT; DRIVER, PROSTHESIS

Model Number	279722550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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 on (b)(6) 2019, during the transforaminal lumbar interbody fusion surgery with expedium dual innie for degenerative lumbar scoliosis at l2, the surgeon performed final tightening of dual innie set screw.It was found out that the tip of the tightener was broken.Although, the surgery was completed without reported any problem.There was no surgical delay and there was no adverse consequence to the patient.This complaint involves one (1) device.
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 examination at the macroscopic level revealed that two of the locking tabs were broken off and other tabs had worn.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the locking tabs underwent a static failure.The absence of rotational deformation and a termination site implies that the locking tabs were broken under a cantilever force.The static overloading led to a fracture of the locking tabs of the device.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 definitive root cause for the device¿s distal end fracturing cannot be positively determined.However, the fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the locking tabs underwent a static failure due to a single, sudden, unexpectedly high force placed on the end of the device.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: XPDM DI INTERMEDT CASTLE TIGHT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8675569
• Report Number: 1526439-2019-51730
• Device Sequence Number: 14081019
• Product Code: HWR
• UDI-Device Identifier: 10705034199382
• UDI-Public: (01)10705034199382
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 279722550
• Device Catalogue Number: 279722550
• Device Lot Number: NW102350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1