MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE DI SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000S

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Not Applicable (3189)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual examination found the initial threads on the setscrew had become torn off.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the setscrew threads becoming torn off cannot be positively determined.However, the noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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 were found, 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

On (b)(6) 2018, the tlif surgery for spinal canal stenosis was performed by using the expedium verse system.The fixed are was l3-l5.During the surgery, the following events were confirmed by the surgeon.The surgeon inserted the correction key (199721000s, lot#: 144277) using an inner set screw after he loosened the inner part of the correction key in a couple of turns.Then, parallel-compression was applied.The final tightening, a torque driver turned idle at l5 (right).As he tried to turn the torque driver again, the thread of the correction key got broken.He tried a new correction key (199721000s, lot#: 154851), but the thread also got broken.At the same time, he found that the thread of the screw (199725740s, lot#: 171524) had been broken.He extracted the broken screw and then inserted a new screw together with a new correction key.The surgeon was successfully completed with a less-than-30-minute delay, and there was no adverse consequence to the patient.

• Brand Name: 5.5 EXP VERSE DI SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount dr.; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7675134
• MDR Text Key: 113583596
• Report Number: 1526439-2018-50640
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721000S
• Device Lot Number: 154851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1