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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721000
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the inserter could not be entered correctly into the correction key and slipped during the final tightening.This damaged the thread of the screw head.There was a surgical delay of 30 minutes.The procedure was completed successfully with replacement screw and set screws.Concomitant devices: unknown torque handle (part# unknown, lot# unknown, quantity 2) unknown rods (part# unknown, lot# unknown, quantity unknown)) this report is for one (1) verse correction key.This is report 11 of 14 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.Visual inspection: the verse correction key was received at us cq.Upon visual inspection at cq, the external threads of the poly lock were stripped and peeled.No other issues were observed with the device.Dimensional inspection: dimensional inspection of the received complaint device cannot be performed due to post-manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed; - expedium verse dual lock assembly: no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint could be confirmed as the external threads of the device were stripped and peeled.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: product code: 199721000, lot number: 256330.The dhr of product code: 199721000, lot: 256330 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 04.10.2019, qty: (b)(4).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.
 
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Brand Name
VERSE CORRECTION KEY
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key12218893
MDR Text Key263393214
Report Number1526439-2021-01500
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public10705034466132
Combination Product (y/n)N
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721000
Device Catalogue Number199721000
Device Lot Number256330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Date Manufacturer Received08/12/2021
Patient Sequence Number1
Treatment
5.5 EXP VERSE FEN SCR 5.0X35; 5.5 EXP VERSE FEN SCR 5.0X35; 5.5 EXP VERSE FEN SCR 5.0X35; 5.5 EXP VERSE FEN SCR 6.0X35; UNKNOWN RODS; UNKNOWN TORQUE DEVICES; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER
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