MAUDE Adverse Event Report: SYNTHES MONUMENT MEDIUM CABLE PASSER; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 391.105

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement.Date of event: unknown.Device is an instrument and is not implanted/explanted.Device history records review was conducted.The report indicates that the: dhr review, part number: 391.105, synthes lot number: p063554, supplier lot number: p063554, release to warehouse date: 07-jan-2010, supplier: (b)(6).Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, which would contribute to this complaint condition.No ncrs were generated during production.As the complaint points towards the brown residues no measurements, no hardening and no further tests were provided.An investigation summary was performed.The investigation of the complaint articles has shown that: per the investigation we did review: all parts that were returned for evaluation in sterilization pouches and have brown residues evident inside the pouch.1x 391.105 / p063554 (cable passer, medium).The provided visual inspection has shown that signs of brown residues could be found inside the pouch.Conclusion: no manufacturing related deviation could be found.As possible root cause we do strong assume that the provided washing and decontamination cycles might have not been repeated often enough in order getting clean instruments.We like to refer on to the document canevasit/phenolic handles attached.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 on an event in (b)(6) as follows: when the reported cab-1 (the name of the surgical tool set assorted in (b)(6)) was about being washed postoperatively, it was found that some brown-colored liquid was leaking from the passer handles.It was uncertain which passer(s) had caused the issue.The devices in question were not used for the patient.This complaint involves 6 parts.This report is 4 of 6 for (b)(4).

• Brand Name: MEDIUM CABLE PASSER
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7202062
• MDR Text Key: 98069982
• Report Number: 1719045-2018-10004
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819719743
• UDI-Public: (01)07611819719743(10)P063554
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.105
• Device Lot Number: P063554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2010
• 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