Catalog Number 130790036 |
Device Problems
Fracture (1260); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Event Description
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Locking metaglene screw head detached from the screw and cannot be locked with base plate during surgery.It was tried on patient but removed once defect observed.The screw was not implanted on patient, surgery continued with another screw.There was no surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # = > (b)(4) investigation summary = > according to the information received, locking metaglene screw head detached from the screw and cannot be locked with base plate during surgery.It was tried on patient but removed once defect observed.The screw was not implanted on patient, surgery continued with another screw.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that no defects were observed in the threads or the tip of the dxtend screw lock d4.5x36mm.The screw was evaluated, and no defects or damage were observed.The screw can be easily screwed and unscrewed in the head of the screw lock.A dimensional inspection was performed for the screw lock and met specifications.A functional test was unable to be performed due to the locking screwdriver not returned.It was not possible to verify if there was any problem with the screwdriver attached to the screw.The complaint condition was not able to be replicated.The overall complaint was unconfirmed as the observed condition of the dxtend screw lock d4.5x36mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing: dwg-8e070132 feature: screw head diameter specification: 4.00 -0.10 mm measured dimension: 3.95 mm device used: mitutoyo digimatic caliper a20276546 id# cd78619 drawing: dwg-8e070128 feature: length screw specification: 36.00 +/- 0.20 mm measured dimension: 36.10 mm device used: mitutoyo digimatic caliper a20276546 id# cd78619 device history lot = > the dhr analysis returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.
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Search Alerts/Recalls
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