MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 8.0X70; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199725870S

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that, during the surgery on unknown date, it was reported that the surgeon could not apply the counter torque to correction key because the surgeon performed inner final tightening although outer final tightening was incomplete.The surgeon did not use the reported screw because the surgeon suspected the breakage of the thread of the screw.The surgery was completed by using alternative screw (p/n and lot number were unknown).After the surgery, the surgeon confirmed under x-ray that there was no broken fragment remained in the patient¿s body.There was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination of the returned screw features some signs of use, including tool marks on its outer surface of its tulip head and extended tabs.The threads of the extended tabs feature a unique pattern in surface wear.Each thread features a shiny, cut surface at the upper and lower edge of the thread, especially towards the inner tip of the thread.Further down, all the threads inside of the tulip head have been torn off.This has left rounded edges where the tulip head threads were previously located.The damage is consistent across all the threads of the tulip head.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.The root cause of the screw threads being torn cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading an inner screw during insertion into the extended tab threads of this poly screw.This would place stress on the threads of the extended tabs and tulip head, potentially resulting in them becoming damaged or 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 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.

• Brand Name: 5.5 EXP VERSE CAN SCR 8.0X70
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8367391
• MDR Text Key: 137556139
• Report Number: 1526439-2019-51382
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034441238
• UDI-Public: (01)10705034441238
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 199725870S
• Device Lot Number: 137566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other