MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE SCREW 7.0 X 55; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721755

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

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

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available.

Event Description

Scoliosis surgery: while correcting the hyper kyphosis cross threading occurred and the threads of the screw head were damaged.We had to break off the tabs to place the dual innie using the approximator.Dr.(b)(6) did not want to remove the complete construct and tried so long until he could lock the innie in the damaged screw head.The first threads of the screw broke and the the threads below were intact and the innie could be locked.During that maneuvers 8 innies have been damaged - metal spreads came out.

Manufacturer Narrative

On 19 sept 16 ms: filed on 1997-21-755 in error.The screw was not involved in the complaint.All screws listed did cross thread / the innie tilted/canted in that area where the gap of threads is.The screw on the picture is just a sample screw to show the gap of the threads.A follow-up will be filed to indicate no product failure.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No product failure.

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 55
• 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: 5956713
• MDR Text Key: 54948157
• Report Number: 1526439-2016-10678
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

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: 199721755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• 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
• Patient Age: 16 YR