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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOCKING SCREW - STERILE; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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| Catalog Number 04.614.508S |
| Device Problems
Mechanical Problem (1384); Device-Device Incompatibility (2919); Migration (4003)
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| Patient Problems
Failure of Implant (1924); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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Additional procode: kwp, mnh, mni.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: on (b)(6) 2020, the patient underwent a posterior cervical spinal fusion at o-t1 treating cervical myelopathy.The procedure was completed without surgical delay.On an unknown date, it was found that setscrews had come off.The surgeon wishes to perform a revision procedure, but it is not scheduled yet.No further information is available.This report is for one (1) ti locking screw - sterile.This is report 3 of 3 for (b)(4).
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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.H3, h6: a product investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that the star drive screw recess has some deformation from use (implantation and explantation).In addition, the part has discoloration on the underneath side, which are most likely a result from contact to the rod.Additionally, the outer thread is in a good condition.Furthermore, there are no visible signs of a product issue or defect.Functional test: based on the complaint description the ¿setscrews had come off¿ (migration/backed-out), we are not able to reproduce and confirm the reported complaint description.Nevertheless, we have done functional test with the received back parts (1x plate and 2x looking screws), the functional test has shown that the part did pass the functional test.Document/specification review: drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Summary: the complaint is confirmed, based on the damage at the implant after explantation.Furthermore, we are not able to reproduce and confirm the reported complaint description.The review of the production history revealed that this item was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Moreover, a review of our complaints data base shows, that there are no other complaints from this article and lot number.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place.The cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the in the investigation flow listed remaining investigation steps are not required.To prevent such problems, we recommend to operate according to the technique guide (036.000.755 dsem/spn/0215/0269 se_819633_aa emea 08/20, page 20 section 13 ¿firmly tighten all occipital and locking screws using the screwdriver shaft stardrive with the handle with quick coupling.To provide counter-torque for tightening the locking screws, the positioning instrument may be used.¿).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part: 04.614.508s.Lot: 6l34953.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 22 oct 2019.Expiry date: 01 oct 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04.614.508.Lot number: 11l0973.Manufacturing site: monument.Release to warehouse date: 27 august 2019.Manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: monument.Release to warehouse date: 16-aug-2019.Part number: 04.614.508, ti locking screw.Lot number: 11l0973 (non-sterile).Lot quantity: 250.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of this product that would contribute to this complaint condition.Component part(s) reviewed: component part dhrs were not reviewed as the reported complaint condition of ¿setscrew backed out¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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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Concomitant devices reported: occipital-pl 4.5/5 med w/50 f/r ø4 ti (part: 04.615.601s lot 5l50781 qty.1); ti locking screw - sterile (part: 04.614.508s lot 6l34953 qty.1); occipital screw (part#: 04.601.114s, lot#: l714345 , quantity: 1); occipital screw (part#: 04.601.114s, lot#: 3l29330 , quantity: 1); occipital screw (part#: 04.601.114s, lot#: 4l84308 , 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.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.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 further reported that the the revision procedure was performed on (b)(6) 2020and all the devices were explanted.
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Search Alerts/Recalls
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