MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE DI SET SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721000

Device Problem Torn Material (3024)

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

Event Date 09/21/2016

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

Correction keys were cross threading and some metal sheared off one of them.Used different correction key surgical delay 20 minutes.

Manufacturer Narrative

Evaluation codes: additional information.Device available for evaluation?, device evaluated by mfr?: corrected data, the verse dual innie correction key set screws [product code: 1997-21-000] were not returned to the complaints handling unit (chu) for evaluation.No indication has been given to the devices¿ availability.As a result, the sample status has been changed to ¿none.¿ should more information and/or the device samples become available at a later date, this complaint file will be reopened and the devices will then receive a full evaluation.A review of the device history record (dhr) for the verse dual innie correction key set screws could not be performed as no lot numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE DI 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): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6030225
• MDR Text Key: 57475747
• Report Number: 1526439-2016-10771
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• 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
• Report Date: 09/21/2016

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: 199721000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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