MAUDE Adverse Event Report: SYNTHES GMBH RONGEUR CURV 4 BLACK; FORCEPS

Catalog Number 03.605.514

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the surgeon had a little difficulty engaging the small fibula preloaded button, so used the larger one which worked.In regard to the indicator on the driver, the black line was visible above the plate.It is unknown if there was a surgical delay reported.The procedure was successfully completed.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) rongeur curv 4 black.This is report 1 of 1 for (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.H3,h6: investigation summary: the received rongeur is in a used condition, there are slight wear marks and discolorations visible, the condition is concordant with a device which was used for several years.The device is in a clean condition with no visible contamination.The complaint was forwarded to our sterility assurance department with following feedback.It is known that the not dismountable design of the complained devices can be a special challenge during reprocessing.Therefore our ¿important information¿ leaflet with reprocessing instructions does list long pre-wash and wash cycles.With these long pre-wash and wash cycles the processability according to iso and aami can be confirmed for these devices.According to the design standard this kind of design should be avoided for new product development.Therefore and as reprocessing of this kind of instrument can be challenging this complaint is deemed to be confirmed although no residues could be detected on the returned instrument.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The received device was returned as a sample for the general allegation against the cleanability of this type of instrument, therefore no further evaluation of this device will be performed.Device history lot part number: 03.605.514, lot number: t948327, manufacturing site: tuttlingen, release to warehouse date: may 04, 2010 (45 devices), may 12, 2010 (1 device).A review of the device history records was performed for the finished device lot number and a ncr #115459 was started because stains formed on the devices after passivation and final cleaning, the instruments were reworked.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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: RONGEUR CURV 4 BLACK
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10853623
• MDR Text Key: 244565638
• Report Number: 8030965-2020-08987
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819316485
• UDI-Public: (01)07611819316485
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.514
• Device Lot Number: T948327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1