MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179771555

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

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

While using straight pedicle probe 279702010 making pilot hole in the ileum, probe was removed and noticed that distal tip was bent.This probe was removed from field and replaced with backup probe.During insertion of iliac screw, 179712985, the expedium quick connect driver, 279712400, sheared off the distal tip of driver into the shank of the polyaxial screw.The driver was removed from the screw and then from the field.The tip of the driver was left inside the shank of the screw as there was no such way to remove as it was wedged inside and broken off flush with the screw.This did not affect surgery outcome.Driver removed from field and replaced by backup driver.179771555 connector was used in construct to connect a rod to a rod.When placing set screw 179702000 into connector, threads of set screw sheared off into connector and damaged threads in connector making it unusable.Both the connector and set screw were removed and replaced with new implants.No further issues noted.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

(b)(4).Visual examination of the connector revealed signs of operative use as evidenced by superficial markings, with threads and drive feature slightly worn.Visual examination of the connector revealed thread damage on both pieces.An image of the connector shows additional material between the connector threads, presumably from the setscrew.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.With the information provided, a definitive root cause for the torn threads on the connector cannot be determined.This damage may have occurred due to cross-threading a set screw upon insertion.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: CONN O/O SD TOP NTCH 5.5X5.5 T
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7538193
• MDR Text Key: 109053145
• Report Number: 1526439-2018-50489
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW196709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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 Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 97