Catalog Number 136523000 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Event Description
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Packaging material a package that was difficult to open and broke in the opening process.The paper on the implant box, on top, was torn and the implant could not be kept sterile during opening.They tried several times, but it just tore into more pieces.No delays affecting time or patient.
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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.H10 additional narrative: 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 : packaging material a package that was difficult to open and broke in the opening process.No delays affecting time or patient.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Note: the complaint device was evaluate and investigated by depuy synthes.Please refer to the attachment (b)(4) investigation summary_signed.Pdf.A manufacturing investigation was performed, and it was identified that there's no deformation on the edge of blister box, the glue transfer between the outer blister box and tyvek has been completed, and there are no blister curling, winding edge, cavity or other defects.This failure mode wasn¿t related to the production process.The root cause of the complaint cannot be determined.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the articul/eze ball 32 +9 bl 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.Device history lot : product code 136523000, lot number d23022112 was manufactured on 20-feb-2023.56 parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is 31-jan-2028.Ifu reference no.Is ifu-0902-00-701.
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Search Alerts/Recalls
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