MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 4.0MM-4.25MM SELF-TAPPING BONE SCREW, 12MM LENGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 183656012

Device Problem Torn Material (3024)

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

Event Date 11/28/2016

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

While final tightening the screw into the eagle plate the screw kept spinning and screw was stripped.Per complaint form: while dr (b)(6) was final tightening the 2 12mm eagle screw, he noticed that they kept spinning like there was poor bone quality.He also noticed that the locking bushing in the plate was removing the top threads of the screws.This made him have to put oversized screws in the patient.This problem has happened a number of times and it seems to happen a lot with the 12mm eagle self tapping screws.

Manufacturer Narrative

Udi: (b)(4).Two (2) eagle swift 12mm screws [product code: 1836-56-012, lot no: avjcmw] were returned to the complaints handling unit (chu) for evaluation.Visual examination revealed that the threads on the two eagle swift screws had become torn.Noted damage suggests that the screws were inadvertently cross threaded with the eagle plate¿s locking bushing causing the threads to become 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.No emerging trends were found requiring further actions.A definitive root cause for the screw threads becoming torn cannot be positively determined.However, noted damage suggests that the screws were inadvertently cross threaded with the eagle plate¿s locking bushing causing the threads to become 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 and 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: 4.0MM-4.25MM SELF-TAPPING BONE SCREW, 12MM LENGTH
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6194045
• MDR Text Key: 63069497
• Report Number: 1526439-2016-10935
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070994
• 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: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 183656012
• Device Lot Number: AVJCMW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• 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