WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT; PLATE, FIXATION, BONE
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Model Number 04.112.620 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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On (b)(6) 2022 during an orthopedic procedure, the plate cracked while being contoured.The procedure was completed successfully using a different plate, there was no surgical delay.This report is for a 2.7 ti va lcp clav pl shaft/ cs1/ lft.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part: 04.112.620-us.Lot: 592p532.Part manufacture date: 07 january 2022.Manufacturing location: elmira.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm ti valcp clav plt shaft/ product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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 2.7 ti va lcp clav pl shaft/ cs1/ lft was observed cracked in the wall of one of the holes from plate.A dimensional inspection for the 2.7 ti va lcp clav pl shaft/ cs1/ lft was unable to be performed due to complex geometry of the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 2.7 ti va lcp clav pl shaft/ cs1/ lft would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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.Drawing/specifications reviewed.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: -wa-lcp clavicle plate 2.7 shaft.Cs1.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.D9.
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Search Alerts/Recalls
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