Catalog Number 620120121 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/06/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that the offset taper adapter total broke when trying to take it out of humeral head trial.
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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: it was reported that the offset taper adapter total broke when trying to take it out of humeral head trial.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that offset taper adapter trial has broken at the bottom, where it assembles the mating device.Fragment was not returned for evaluation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and excessive forces during the assembling and/or disassembling process.The inhance¿ shoulder system anatomic surgical technique (103832905 rev b) was reviewed, the following statements regarding the relevant parts of the process that could have led to the allegation were found: the humeral head trials are offered with a modular offset taper adapter trial.To assemble the two components, orient the offset taper adapter trial so that the taper and laser line are facing up.Align the laser mark on the offset taper adapter trial with the c and laser line on the underside of the humeral head trial so that the flexible nub on the offset taper adapter trial sits with the notch on the underside of the humeral head trial marked c.Then apply pressure to snap the two components together.To remove the humeral head trial, assemble the head distractor to the impactor handle and place between the resection and the humeral head.To remove the offset taper adapter trial from the humeral head trial, rotate the offset taper adapter trial counterclockwise until the ramps unlock it from the head.Once the offset taper adapter trial reaches the e = eject position, it will engage the ramp and come out of the humeral head trial.The overall complaint was confirmed as the observed condition of the offset taper adapter trial would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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