MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM 4.5 TI SINGLE INNIE SET SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186100001

Device Problem Torn Material (3024)

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Elongated flake has loosen from single inne while inserting.Single innie has been exchanged and surgery was completed successful.

Manufacturer Narrative

(b)(4).Complaint sample received.A follow up will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).One (1) exp 4.5 ti single innie was returned for evaluation.Tabs of unknown screws were also returned.Visual examination of the exp 4.5 ti single innie revealed that threads were completely peeled and separated.The tabs showed signs of operative usage.The exact part and lot number combination is unknown; therefore, the manufacturing or receiving inspection records could not be reviewed.No emerging trends were found requiring further actions.A definitive root cause cannot be determined for the peeling of the threads on the single innie set screw with the information provided.A potential root cause could be due to inadvertently cross-threading the set screw with the screw during the insertion and subsequent attempts to tighten the set screw, placing enough force on the threads to tear them off completely.As no systemic trends have been identified in this complaint file requiring immediate actions, this complaint file will be closed with no further actions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM 4.5 TI SINGLE INNIE SET SCREW
• 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: 6534536
• MDR Text Key: 74160952
• Report Number: 1526439-2017-10312
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

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 Catalogue Number: 186100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/09/2017; 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1