MAUDE Adverse Event Report: SYNTHES GMBH RONG STRAIG W/6 L330; RONGEUR

Catalog Number 03.605.002

Device Problems Contamination /Decontamination Problem (2895); Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: reporter is a j&j employee.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.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.

Event Description

Device report from synthes reports an event in germany as follows: during the cleaning process it was mentioned that the punches and rongeurs to a proper and successful cleaning, but it was not possible to eliminate visible contamination.The problem with the drum tongs and rongeurs is that they can be dismantled.Our drum tongs (rongeurs) and punches of this generation do not allow dismantling (dismantling for proper cleaning in the aemp).Despite repeated attempts with manual pre-cleaning, ultrasound cleaning and subsequent mechanical cleaning and disinfection, detectable blood residues remain on the surfaces via hemocheck-s.No patient harm.No surgery delay.This report is for one (1)rong straig w/6 l330.This is report 3 of 6 for complaint: (b)(4).

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.H10 additional narrative: h3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot # provided is not a valid lot number for this device, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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.D10: date of concomitant therapy is (b)(6), 2022.

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.H3, h4, h6 investigation summary: 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 rong straig w/6 l330 was observed with spots of foreign substance along the surface of the device.No signs of blood residues were identified.Since corresponding sterilization documents were not provided, it is not possible to establish a root cause of the observed condition.The important information (with cleaning and sterilization instructions) document was reviewed.Following relevant statements were found.Prior to steam sterilization, place the product in an approved sterilization wrap or container.The first and most important step in reprocessing all re-usable instruments is thorough (manual and/or mechanical) cleaning and rinsing.Thorough cleaning is a complex process whose success depends on various interrelated factors: water quality, quantity and type of cleaning agent, cleaning method (manual, ultrasonic bath, washer/disinfector), thorough rinsing and drying, proper product preparation, time, temperature, and thoroughness of the individual responsible for cleaning.All devices must be thoroughly cleaned and inspected prior to sterilization.Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection.During cleaning, only use cleaning agents that are labelled for use on medical devices and in accordance with the manufacturer¿s instructions (e.G.Temperature, contact time, and rinse time).Cleaning agents with a used dilution ph of within 7¿9.5 are recommended.Highly alkaline conditions (ph >11) can damage components/devices, such as aluminum materials.Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products).Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes.Only place synthes devices with items of similar metallic composition together in an ultrasonic cleaner.Soiled or used synthes devices should not be loaded into a case for cleaning in a mechanical washer.Soiled synthes devices must be processed separate from trays and cases.A dimensional inspection for the rong straig w/6 l330 was not performed as it is not applicable to the complaint condition.A functional test was performed and the device was able to works correctly.The complaint condition was not able to be replicated.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 rong straig w/6 l330 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? yes, reviewed dimensional inspection: n/a.Device history part number: 03.605.002 lot number: t181668 manufacturing site: tuttlingen release to warehouse date: 04-apr-2019.A review of the device history records was performed for the finished device lot number and an nc nr-0121256 was started because the monthly monitoring of water quality found that the toc value was exceeded.For further investigation a capa-009137 was started.The product investigation revealed no deviations.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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: RONG STRAIG W/6 L330
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16018525
• MDR Text Key: 308363004
• Report Number: 8030965-2022-11339
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.002
• Device Lot Number: T811668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LAMINECT-PUNCH 40°ANGL W/2 L330; LAMINECT-PUNCH 40°ANGL W/4 L330; LAMINECT-PUNCH 40°ANGL W/6 L330; RONG ANGL-UPWARDS W/3 L330; RONG STRAIG W/4 L330