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

Catalog Number 199721000

Device Problem Torn Material (3024)

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) verse dual innie correction key setscrew [product code: 1997-21-000] was returned to the complaints handling unit (chu) for evaluation.Visual examination revealed that the threads on the correction key setscrew was sheared off.Noted damage suggests that the correction key setscrew was 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 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.A definitive root cause for the correction key setscrew threads becoming sheared off cannot be positively determined.However, a likely root cause is that the correction key setscrew was 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 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

Rep left voicemail for verse correction per complaint form: surgeon performed an l5-s1 bilateral fusion.We placed 6 x 40 mm verse screws at all four pedicles.We were placing the rods and used unitized set screws at s1 pedicles and 40 mm rods bilaterally.The surgeon placed correction keys item 1997-21-000 in both l5 screws to hold the rods.Sales rep instructed surgeon to tighten the outer part of the correction key on the left l5 pedicle completely to lock the head of the screw.He confirmed he tightened it.Then we distracted screws on the left side confirmed xray and tightened the inner screw on the correction key.We did the same thing on the right side.We final tightened the outer and inner screw on the right side of the patient.The left side but there was an issue on the left.The inner set screw, screwed all the way through the outer screw.We removed that correction key and placed a new one.It took less than a minute to correct and the surgery was completed without complications successfully.I need to replace the set screw and send this one in.Sales rep spoke with surgeon on how to avoid this next time by final tightening the outer set screw of the correction key first thing when it is placed.

• Brand Name: 5.5 EXP VERSE DI SET SCREW
• 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: 6274343
• MDR Text Key: 65639791
• Report Number: 1526439-2017-10055
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2016

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: 199721000
• Device Lot Number: ATHD9Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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: 57 YR