MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	199721640
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, during the procedure, there were problems for the locking screws working because they did not block the bar after performing the correction required by the specialist.This caused the damaged locking screws and the transpedicular screws with damaged threads to be replaced.This affected the surgical time, extending the time by approximately one (1) hour.The issue also affected the patient because more anesthesia time was required.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that 5.5 exp verse screw 6.0 x 40 has stripped.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined with the evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 5.5 exp verse screw 6.0 x 40 and the event description would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device.Part: 199721640; lot: 372848; the product was released on: 17-may-2023.Manufacturing site: jabil le locle.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that no further surgical intervention was necessary.There were no fragments of any type of damaged instruments in the patient.Damage is understood to be the deficiency in the operation of the equipment listed in the report; the malfunction of these parts affected other references such as the locking screws and transpedicular screws.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information was received and translated as follows: ref 299704310 expidium tab breaker damaged, ref 29704220 damaged in equipment 500070028.3 screws expidium ref 1997217665 batch: 229716 (2) and batch 341520 (1), 1 screw ref 199721640 batch 372848 are damaged due to closing screws in bad shape.6 screws ref 199721000 don't block the bar and in the end the screw is damaged.2 refs 199721001 are damaged because at the moment of change them, they were already damaged and when tightening them the screw threads are damaged.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 2400 ; SZ 2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20224457
• Report Number: 1526439-2024-02443
• Device Sequence Number: 19709214
• Product Code: NKB
• UDI-Device Identifier: 10705034442280
• UDI-Public: (01)10705034442280(10)372848
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 199721640
• Device Lot Number: 372848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 02/08/2025; 02/17/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/28/2024; 02/13/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male