Product complaint # (b)(4).Date of event is an unknown date.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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.
|
Product complaint # (b)(4).Investigation summary : according to the information received, "hcp is reporting a defective instrument without telling details." the product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo/x-ray investigation revealed that attune system impactor had stripped/worn/twisted/cross threaded & scratched/nicked.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune system impactor would contribute to the complained device issue.Based on the investigation findings, end of life problem identified 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 : device history record review for: product description: attune system impactor product code: 254411003.Lot number: bfa24ee.1) quantity manufactured: (b)(4), 2) date of manufacture: 1/10/2021, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: none, 5) ifu-0902-00-836.
|