MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CROSS CONNECTOR TIGHTENER; DRIVER, PROSTHESIS

Catalog Number 288307200

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2014

Event Type  malfunction  

Manufacturer Narrative

Two mountaineer head to head cross connector tighteners (product code: 2883-07-200, lot numbers: gb0208 and gb45968) were returned to the complaints handling unit (chu).Torque testing was conducted on the tightener.The tighteners are out of specification.The tighteners were further inspected.The gb0208 tightener featured a heavy amount of rust on all metallic parts from inside the handle, including its ratcheting feature.The interior of the handle was mostly dry with dirty lubricant.This may have contributed to the tightener ratcheting out of spec.The tightener from lot gb45968 did not feature the large amount of rust that the tightener from gb0208 did.There were no readily visible defects that would lead to the tightener exerting a higher than anticipated amount of torque required for the tightener to ratchet.Minor markings/galling may have contributed to this.It has been noted that the rusted tightener from lot gb0208 required a higher average torque value to ratchet and featured a greater standard deviation than the tightener from lot gb45968.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.The root cause of the tighteners exerting excessive torque on the inner screws cannot be positively determined from the sample and the information provided.A potential root cause may be rust and damage in combination with the advanced age of the instrument from lot gb0208.There is less evidence of such damage to the tightener from lot gb45968.However, it does feature some galling/markings that may have inhibited its movement during rotation/ratcheting.This resulted in excessive force being needed in order for the tighteners to ratchet.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.

Event Description

C2-c7 instrumentation was performed using the mountaineer system for the patient with cervical spondylosis.During final tightening of the hh cross connector, the inner screw was placed without problem, however, the outer nut could not be fixed onto the inner screw since torque was not applied with the tightener.The surgeon replaced the implants and re-tried, but could not apply torque again.The surgeon gave up final tightening and completed the case with 15-minute delay.After surgery, a metal piece was found in the tightener.Sem (b)(6) 2014: clarification requested of affiliate.Sem (b)(6) 2014: request for further clarification.Did cross connector tightener's end spin during tightening or did the torque feature not function? also, from where did the broken piece of metal come? sem (b)(6) 2014: reply: the tightener was spinning/not grabbing during tightening.The origin of the metal piece found in the tightener is unknown.

• Brand Name: CROSS CONNECTOR TIGHTENER
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5089522
• MDR Text Key: 26484903
• Report Number: 1526439-2015-10817
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 11/19/2014

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
• Device Operator: Physician
• Device Catalogue Number: 288307200
• Device Lot Number: GB0208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1