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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721740
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: additional procode: kwp, kwq, mnh, mni, osh.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2020, the threads on an 7.0x40mm expedium verse screw at left l5 came dislodged and prevented the verse correction key from threading down entirely making it impossible to final tighten the setscrew.The screw was removed and replaced with another 7.0x40mm expedium verse screw.The procedure was successfully completed with a surgical delay of ten (10) minutes.The patient status/outcome is unknown.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown ).Unknown locking/set screws (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) 5.5 exp verse screw 7.0 x 40.This is report 1 of 1 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.H3, h6: investigation summary investigation flow: device interaction/functional visual inspection: the 5.5 exp verse screw 7.0 x 40 (part #: 199721740, lot #: 258745 ) was received at us cq.Visual inspection of the complaint device showed the expedium verse screw head (part # 887042533) had scratches and a worn out thread.The internal hexalobe of the poly screw shank (part #: 887046463) was present but dented and worn out as well.There was a deep scratch on the screw head similar to a ring mark.No physical damage or defect was reported on the double helical external thread of the screw.The cap (part # 887042534) could be seen but no damage could be reported.The ring was not visible.The screw could pivot freely without any resistance.Functional test: a functional assessment was not performed with the complaint device due to the post manufacturing damage of the device assembly.However due to the deep scratch on the screw head, and the screw pivoting freely without resistance, it is possible that the ring was broken and fall off.Can the complaint be replicated with the returned device? yes, there could be a defect due to the way the screw was pivoting that could contribute to the complaint condition.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing condition of the returned device and due to requiring destruction of the device to accurately dimensionally inspect.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed for the 5.5 exp verse screw 7.0 x 40 (part #: 199721740, lot #: 258745 ) as there were physical damage to the returned device assembly.Per the investigation it is likely that the ring was broken and fall off during usage of the device.Additionally, the hexalobe of the screw shank was dented and rounded on the edges.This could be due excessive forces applied to tighten the screw.No root cause could definitely be determined for the reported complaint condition but it is likely excessive force application could have contributed to the device failure and making it difficult to final tighten the screw set.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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: the dhr of product code 199721740, lot 258745, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on october 21, 2019.Qty.(b)(4).The dhr was electronically reviewed.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
5.5 EXP VERSE SCREW 7.0 X 40
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10421091
MDR Text Key203533117
Report Number1526439-2020-01489
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442112
UDI-Public(01)10705034442112
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,health
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721740
Device Catalogue Number199721740
Device Lot Number258745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Date Manufacturer Received09/21/2020
Patient Sequence Number1
Treatment
UNKNOWN LOCKING/SET SCREWS; UNKNOWN TIGHTENER
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