MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000

Device Problems Device Damaged by Another Device (2915); Torn Material (3024)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Twelve (12) verse dual innie correction key setscrews [product code: 1997-21-000] were also returned to the chu for evaluation.Visual examination revealed that all twelve setscrews demonstrated some indication of torn and sheared off threads.Noted damage suggests that the correction key setscrews were likely not properly seated during insertion and inadvertently cross threading occurred coupled with unexpectedly high amounts of force being placed on the threads resulting in them being torn.A review of the manufacturing or receiving inspection records could not be performed the lot numbers are illegible.No emerging trends were found requiring further actions.A definitive root cause for the threads becoming torn and sheared off the correction key setscrews cannot be positively determined.However, a likely root cause is that the correction key setscrews were likely not properly seated during insertion and inadvertently cross threading occurred coupled with unexpectedly high amounts of force being placed on the threads resulting in them being torn.As there has been no systemic trends requiring immediate action observed, this complaint file will be closed with no further action required.

Event Description

Feedback from surgeon: by now i have done 5 operations with the expedium verse implants.4 out of 5 were deformity surgery.The last case i have done was on tuesday this week.The case: (b)(6), male patient with severe cerebral palsy (gmfcs- level 5) w/ a 120° neurogenic thoraco-lumbar scoliosis with shoulder and pelvis obliquity.Aim of surgery: improve sitting and nursing of the patient.Surgery: correction spondylodesis t2-ilium.Problem with the implants: in the scoliosis cases with no severe curves (<60-70°) the implants work pretty well , because they do not get stressed specially the screw head is not stressed! but in severe cases (more than 80-90° and severe rotation of the vertebra) the screw heads seem to have more space in the verse quick stick sleeve and the verse quick stick tube , the verse facilitator and the flex clip reducer and that¿s why the blocker (flate screws, correction screws ) do no run correctly in the screw head and cant.The screw head extension is may be too soft.The diameter of the reichel sleeve, the tube etc.May be too wide.

Manufacturer Narrative

Verse dual innie correction key setscrew is a concomitant device.There is no indication that the set screw caused or contributed to the event.The tearing of the set screws was caused by the damaged flex clip and flex clip reducer which will be classified as torn.Torn set screws have been changed to concomitant upon further evaluation.Set screws were originally reported as torn based on information available.The complaint was discussed during a smt meeting on (b)(6) 2017.After inspecting the returned flex clip the device showed signs that the plastic bushing between the two parts of the inner reducer sub assembly was damaged.This indicates that the inner tube was advanced beyond the zero etch line on the outer clip/sleeve and then bottomed out on the outer sleeve.As the surgeon continued to apply more torque inner reducer sub assembly, the plastic bushing collapsed and the spring tip of the most distal component of the inner reducer sub assembly deformed inward, occluding the access to the screw head, making passing the set screw impossible.It is hypothesized that the surgeon did not have the flex clip fully clipped onto the screw head, which therefore allowed the surgeon to believe he had fully reduced the rod, but could not get the set screw to start in the screw head.In response the surgeon applied more torque to the reducer which only caused the device to deform as described above which then continued to make getting the set screw started impossible.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VERSE CORRECTION KEY
• 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; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6118228
• MDR Text Key: 60571975
• Report Number: 1526439-2016-10874
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 199721000
• Device Lot Number: ILLEGIBLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 21 YR