MAUDE Adverse Event Report: SYNTHES MONUMENT LARGE CABLE PASSER-45 DEG ANGLE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	391.108
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 available for evaluation?: date returned to manufacturer.Device history records review was conducted.The report indicates that the device history for the returned part are as follows: part number: 391.108: as the complaint points towards the brown residues no measurements, no hardening and no further tests were provided.Synthes lot number: p076240.Supplier lot number: p076240.Release to warehouse date: 14-jul-2010.Supplier: (b)(4).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 pouche.1x 391.108 / lot p076240 (cable passer, large, 45° angle.The provided visual inspection has shown that signs of brown residues could be found inside the pouche.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 or Problem 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 2 of 6 for (b)(4).

• Brand Name: LARGE CABLE PASSER-45 DEG ANGLE
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 7202055
• Report Number: 1719045-2018-10002
• Device Sequence Number: 10972840
• Product Code: LXH
• UDI-Device Identifier: 07611819719781
• UDI-Public: (01)07611819719781(10)P076240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 391.108
• Device Lot Number: P076240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1