MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721640S

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).One 5.5 expedium verse screw 6.0x40 was received by the customer quality unit.Visual examination of the screw revealed significant wear with severe indentation marks.It was found that the initial thread on the screw was torn.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn off.A device history record review found no issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn thread on the 5.5 expedium verse screw 6.0x40 cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn off.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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

The following was reported: product code : 199721640s.Lot/batch/exp: 165937.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? a new screw was inserted and final tightening was achieved.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? if the item is returned from cssd following decom please give a detailed explanation of the event: mr (b)(6) suggested that he had final tightened the set screw (199721001s) with the torque limiting handle and x25 driver.When he snapped the ears the unitized nut came with the ears meaning the rod wasn¿t effectively reduced into the head of the screw.Mr (b)(6) tried to insert the nut using the reduction tool and couldn¿t engage the threads of the screw head.After multiple attempts he removed the nuts from the other screws (l4,5,s1), inserted a new screw, reinserted the nuts and completed final tightening of the construct.

• Brand Name: 5.5 EXP VERSE SCR 6.0X40
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7949435
• MDR Text Key: 123191891
• Report Number: 1526439-2018-50971
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034444024
• UDI-Public: (01)10705034444024
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 199721640S
• Device Lot Number: 165937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• 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
• Patient Outcome(s): Other