MAUDE Adverse Event Report: SYNTHES GMBH PERIOSTEAL ELEVATOR 6 CRVD BLD-STR EDGE

Catalog Number	399.40
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from canada reports an event as follows: it was reported that on january 29, 2024 during sterilization, the handle material of the periosteal elevator in question was leaking/staining.The event occurred outside of surgery.There was no patient involvement.No further information is available.This report is for one (1) periosteal elevator 6 crvd bld-str edge.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
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.H11 additional narrative: h6: a product investigation was conducted.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample found surface of the shaft is found with numerous scratches and dents; this condition is an end of life indicator.Furthermore, signs of foreign substance were not observed.However, phenolic handle of the device presents light signs of fading of the brown color.The sterilization bag in which the device was decontaminated and received prior to investigation presents evidence of brown staining.The letter for sustaining engineering documents that the phenolic material, not this specific device, has been tested through numerous reprocessing cycles and slight color changes were noted but no signs of severe degradation such as bleeding or erosion were found.The returned instrument is 12 years old and the slight fading noted on the phenolic handle would be expected for a device that has gone through numerous reprocessing cycles.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.A dimensional inspection was unable to be performed due to the condition of the complaint.The overall complaint was confirmed as the observed condition of the periosteal elevator 6 crvd bld-str edge would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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.H6: device history record (dhr) review conducted: part number: 399.40 lot number: t979398 manufacturing site: (b)(4).Release to warehouse date: 25-may-2012.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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.

• Brand Name: PERIOSTEAL ELEVATOR 6 CRVD BLD-STR EDGE
• Common Device Name: ELEVATOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19362299
• Report Number: 8030965-2024-06546
• Device Sequence Number: 3785426
• Product Code: HTE
• UDI-Device Identifier: 10886982202789
• UDI-Public: (01)10886982202789
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 399.40
• Device Lot Number: T979398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown