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

Catalog Number 199721000S

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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) 2017, the surgery for lumbar vertebral canal stenosis was performed by using the verse cannulated screw and verse collection keys.The fixed area was l4 ¿ l5.Although the outer torque was fastened after inserting the collection key via the facilitator, a sound which the torque was supposed to be spinning around could not be heard (cross-threaded).The surgeon tried this several times.Because even the inner torque could not be fastened thereafter, the screw was removed and replaced with a new one.The surgery was completed with a 40-minute-delay, and there was no adverse consequence to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Visual evaluation of the returned device revealed that the threads on set screw was torn and peeled.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.A definitive root cause cannot be positively determined.However, based on the visual evaluation of the returned sample, the possible cause of the defect is the instrument been subjected to unanticipated torsional forces during use or wear and tear over time.This will put more pressure on the threads of the set screw causing it to be torn and peeled.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.

• Brand Name: 5.5 EXP VERSE DI SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SARL; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7205231
• MDR Text Key: 97950899
• Report Number: 1526439-2018-50051
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: 10705034466125
• 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,Followup
• Report Date: 12/21/2017

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: Health Professional
• Device Catalogue Number: 199721000S
• Device Lot Number: 144278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1