MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 TI EXP FAS2 SCREW 7.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721740

Device Problem Torn Material (3024)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon was attempting to lock the correction key at l5 and s1 on the left side of a distal degen scoli (t10-pelvis).The rod was contoured and inserted into the screw tabs and then ¿dialed in¿ to the screw head with sequential correction keys (finger tightened).At certain apical points he placed wedding bands onto the screws tabs, however, on final tightening the tabs prevented the instruments from being passed through to the set screws so the rings were replaced with quick sticks.On performing final tightening at s1 the surgeon vocalised that the castle tightener kept ¿jumping¿ and didn¿t feel right ¿ it wouldn¿t torque.He took out the correction key and used a new one.He had the same issue that it wouldn¿t lock.He took the correction key out and it had warped.At this point he removed all the correction keys on that side.He removed the rod and then took out the screw at s1.The inside of the screw tulip was warped ¿ the threads had closed together and there were shards of metal that he pulled out which looked like the threads from the set screws or the thread from inside the screw.All of these were sent for decontaminating and i will collect for return.The surgeon replaced the screw, and the l5 screws which he also felt may have been damaged.He replaced the rod and completed the correction again but used unitised set screws at s1 to avoid having to lock it twice.He corrected the opposite side (using unitised set screws at the s1 screw).

Manufacturer Narrative

The two 5.5 ti expedium fas2 7.0x40mm screws (product code: 1997-21-740, lot number(s): unknown), the two 5.5 expedium verse dual innie set screws (product code: 1997-21-000, lot number(s): unknown), the unknown rod (product code and lot number unknown), and the unknown screw (product code and lot number unknown) were not returned to the customer quality unit (cqu).While it was initially identified that the parts were available, three requests for their return were made without the sample or a tracking number being returned.A review of the dhr could not be performed as no lot numbers were provided.Since these parts were not returned, no lot numbers could be taken directly from the samples.Without the lot numbers, no review of their manufacturing records could be completed.Without the device we are unable to confirm the reported issue or identify the root cause.If the device is returned at a later date, the complaint will be reopened and the sample will be evaluated.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.Device not returned.

• Brand Name: 5.5 TI EXP FAS2 SCREW 7.0 X 40
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6158876
• MDR Text Key: 61901465
• Report Number: 1526439-2016-10915
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

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: 199721740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1