MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MOUNTAINEER; DRIVER, PROSTHESIS

Model Number	288307200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings.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
When torquing down the outer nut on the h/h conn plate, the driver and nut kept shearing off the top of the inner screw.The surgeon was not able to use the h/h conn plate in his construct because of this.
Additional Manufacturer Narrative
Udi: (b)(4).One mountaineer head to head cross connector tightener was returned to the customer quality unit for evaluation on november 2, 2017.There was no immediately visible damage found to the mountaineer head to head cross connector tightener.As a precaution, torque testing was conducted on the tightener using a load cell.The evaluation set up consisted of a single test frame.A 5.5mm rod was secured in the load cell with the tightener attached to the rod.The tightener was then torqued until it reached its limit.This was performed eighteen (18) times.This head-to-head cross connector tightener provides the correct amount of torque for its specifications.There were no issues found in the use of this instrument.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.No emerging trends were found requiring further actions.No root cause analysis is necessary at this time for the mountaineer head to head cross connector tightener as no product failures have been identified during the course of this investigation.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 requiring immediate action have been observed, 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: MOUNTAINEER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7017696
• Report Number: 1526439-2017-10978
• Device Sequence Number: 13749106
• Product Code: HWR
• UDI-Device Identifier: 10705034221533
• UDI-Public: (01)10705034221533
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 288307200
• Device Catalogue Number: 288307200
• Device Lot Number: GB72649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR