MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE CAN SCR 7.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199725745S

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the 5.5 exp verse can scr 7.0x45 reveals signs of operative use as evidenced by superficial markings, with its lead thread peeled off which consists of approximately 1/4th turn of thread material, which is attached to the screw.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the 5.5 exp verse can scr 7.0x45 cannot be determined.This damage may have potentially occurred due to cross-threading a set screw upon insertion.Tightening the set screw while it is cross threaded places an unexpectedly high amount of force on the threads both the set screw and the polyaxial screw threads.This can potentially result in damage and/or tearing to the threads of both the set screw and poly-axial screw.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 were found, 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.

Event Description

On (b)(6) 2018, the surgery was performed by using the expedium verse system.The fixed are was l3.During the surgery, the following event was confirmed by the surgeon.At the time of tightening a rod, when trying to insert a set screw (part#: unknown), the set screw could be inserted up to the head part of the reported screw (199725745s), but it could not be inserted any more regardless of his several attempts.He broke the screw tabs and again tried to insert the set screw with a clip-on-device (part#: unknown), but the set screw could not fit this device.He extracted the screw (199725745s) in question and replaced it with another new one.The surgery was successfully completed with a less-than-30-minute delay, and there was no adverse consequence to the patient.We are requested by the surgeon to make an in-depth investigation on the root cause of this event.

• Brand Name: 5.5 EXP VERSE CAN SCR 7.0X45
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount dr.; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount dr.; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7633311
• MDR Text Key: 112423812
• Report Number: 1526439-2018-50582
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440934
• UDI-Public: (01)10705034440934
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725745S
• Device Lot Number: 147919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other