MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186100001

Device Problem Torn Material (3024)

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

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Surgeon had initially tightened the set screws with standard set screw driver.When going back to final tighten, the set screw did not seem to tighten/seat properly.The surgeon thought the torque driver slipped, but it appeared that the set screw looked broken.After backing out the set screw, it was clear that the part of the threads had broken off in the process of tightening.This occurred on 2 set screws in the construct during final tightening and it is unclear whether anything was cross-threaded or what may have been the problem.

Manufacturer Narrative

Udi: (b)(4).One (1) expedium 4.5 ti single innie set screw [product codes: 1861-00-001] was returned to the customer quality unit (cqu) for evaluation.Visual examination revealed that the set screw (lot number illegible) had torn threads.Observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.A review of the device history record (dhr) for the expedium 4.5 ti single innie set screw could not be conducted.It should also be noted that the set screw had illegible lot number, and as such, the manufacturing records could not be conducted.As lot number is illegible on the surface of the device it is impossible to identify its lot number and perform a manufacturing record search.No emerging trends were found requiring further actions.A definitive root cause for the set screw becoming torn cannot be positively determined.However, observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.As 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.

• Brand Name: EXPEDIUM
• 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): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6952239
• MDR Text Key: 90056378
• Report Number: 1526439-2017-10843
• 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: 09/26/2017

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 Model Number: 186100001
• Device Catalogue Number: 186100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR