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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI TRANSCONNECTOR LOCKING SCREW; ORTHOSIS,CERVICAL PEDICLE
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| Model Number 04.614.522 |
| Device Problem
Device Handling Problem (3265)
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| Patient Problem
No Patient Involvement (2645)
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| Event Date 01/16/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional pro-codes: kwp, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.
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Event Description
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It was reported that on (b)(6) 2020, the surgeon was performing c2-6 posterior cervical fusion procedure using the 4.0 synapse system.Near the end of the case, after the surgeon applied two transconnector locking set screws and eight (8) titanium locking screws to the remaining screws, the doctor then finally tightened all ten (10) set screws.The physician attempted to seat a medium synapse top loading transconnector to the transconnector set screws.He then applied a 7.5mm transconnector locking nut to the left side of the transconnector but when he attempted to apply and seat the right side the transconnector would not seat.He loosened the nut on the left side to see if that would help, but it would not seat.He tried this a number of times, but it clearly wouldn¿t seat properly.They used medium angled top loading transconnector but had the same result.When he was removing the 7.5mm but it would not release and he said it felt as if the head of the pedicle screw splayed open.He decided to remove the transconnector nuts, locking screws and the transconnector and simply use just the standard titanium locking screws.He wants to know why the transconnector would not seat and if this has happened in the past.He said the center of the transconnector was not being held up by the lamina.There was a surgical delay of 15 minutes.The procedure was successfully completed.There was no patient consequences.Concomitant devices reported: unknown transconnector locking set screws (part# unknown, lot# unknown, quantity unknown).Unknown titanium locking screws (part# unknown, lot# unknown, quantity unknown).Unknown transconnector nut driver (part# unknown, lot# unknown, quantity 1).Unknown pedicle screw (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) ti transconnector locking screw devices.This report is 1 of 3 for (b)(4).
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Event Description
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Concomitant devices reported: transconnector locking set screw (part# unknown, lot# unknown, quantity unknown); titanium locking screws (part# unknown, lot# unknown, quantity unknown); transconnector nut driver (part# unknown, lot# unknown, quantity 1); pedicle screw (part# unknown, lot# unknown, quantity unknown); ti transconnector locking screw (part # 04.614.522, lot # unknown, quantity 2); ti transconnector locking nut 7.5mm ( part # 04.614.521, lot # unknown, quantity 3); angled ti top loading transconnector/medium (part # 04.614.551, lot #: 7348874, quantity: 1), ti top loading transconnector medium (part # 04.614.516, lot #: 22p8031, quantity: 1).
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Manufacturer Narrative
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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.Updated concomitant devices.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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Manufacturer Narrative
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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.Investigation flow: device interaction/functional.Visual inspection: the ti trans connector locking screw (p/n: 04.614.522, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the device was received assembled with the angled ti top loading transconnector/medium (p/n: 04.614.551) and ti transconnector locking nut 7.5 mm (p/n: 04.614.521).No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device.The attempt to disassemble the ti trans connector locking screw from the angled ti top loading trans connector/medium and ti trans connector locking nut 7.5 mm failed as the devices were stuck.The mating devices were investigated under a different pi in the same pc.Can the complaint be replicated with the returned devices? yes.Dimensional analysis: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: since the lot number is unknown, manufactured date of the device is unidentified, reflecting the current revision of the drawings are reviewed complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed for the ti trans connector locking screw (p/n: 04.614.522, lot #: unk).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 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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