Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: it was reported that on (b)(6) 2023, the product in question was used in the surgery via bha on the right hip joint.In the surgery, the surgeon mentioned that the size markings on said product were very hard to read.The surgery was completed successfully without any surgical delay.No further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device confirm the reported allegation.The s/c & mod cath trl 44/28 was found worn, this condition caused the etch to be illegible.No other defect was found.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the s/c & mod cath trl 44/28 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life and 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 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.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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