MAUDE Adverse Event Report: DEPUY SPINE INC EXP 4.5 TI SINGLE INNIE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186100001

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  Injury  

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 4.5 titanium expedium with cobalt chrome rods were used.When final tightening 2 of the set screws with the torque limiting driver, the threads sheared off of the set screws and they had to be replaced.They were already down into the screw head when the final torque was applied.No adverse consequence to the patient or additional anesthesia needed.

Manufacturer Narrative

Product complaint #
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> (b)(4).Visual examination found that the threads on the set screw were 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.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.With the information provided, a definitive root cause for the torn threads 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.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, 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: EXP 4.5 TI SINGLE INNIE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8631727
• MDR Text Key: 145767841
• Report Number: 1526439-2019-51684
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034103846
• UDI-Public: (01)10705034103846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• 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,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186100001
• Device Catalogue Number: 186100001
• Device Lot Number: RL235105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7 YR