MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM VERSE SPINE SYSTEM CORRECTION KEY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199721000S

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during spinal fusion for lumbar burst fracture, the screw and the correction keys were used at l1.The surgeon finished locking the rod and temporary screw but was unable to tighten the screw and the correction keys with the screwdriver.When the surgeon used the v3d compressor/distractor, the device did not move smoothly.There was a surgical delay of thirty (30) minutes.The procedure was completed successfully.No further information is available.This report is for one (1) expedium verse spine system correction key.This is report 3 of 3 for (b)(4).

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.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 5.5 exp verse di set scr the threads of the set screw were broken, and broken piece were not returned no other issues were identified.The dimensional inspection was not performed due to alleged complaint condition.Functional test cannot be performed but the alleged will not tighten condition can be confirmed since the threads were broken might have caused the alleged complaint condition.The observed condition 5.5 exp verse di set scr in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the 5.5 exp verse di set scr.While no definitive root cause could be determined, it is probable that the 5.5 exp verse di set scr the threads were broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 199721000s.Lot : 154851 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 09.10.2017.Qty: 210.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM CORRECTION KEY
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 50461 west pontiac trail; wixom, MI 48393 ; 6103142063
• MDR Report Key: 12527592
• MDR Text Key: 274358390
• Report Number: 1526439-2021-02069
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000S
• Device Catalogue Number: 199721000S
• Device Lot Number: 154851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE CAN SCR 7.0X45; 5.5 EXP VERSE DI SET SCR; UNKNOWN RODS; UNKNOWN SCREWDRIVERS; VIPER3D COMPRESSOR/DISTRACTOR; VIPER3D COMPRESSOR/DISTRACTOR