MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRFX ADV - SM TRIAL/DILATOR; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number 254828

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The lot number is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 9 for the same event.It was reported by the sales rep that prior to an anterior cruciate ligament reconstruction procedure during sterilization, the sales rep's intrafix small trial, intrafix large trial, intrafix extra large trial, intrafix small 23mm sheath inserter, intrafix large 23mm sheath inserter, intrafix small 30mm sheath inserter, intrafix large 30mm sheath inserter, intrafix extra large 30mm sheath inserter, and intrafix hex driver all had blood residue in the cannulated portions of the devices.The sales rep stated that the facility attempted to sterilize the devices three times and the devices could not be cleaned.The case was completed with another set with no patient harm or delay.The sales rep could not provide lot numbers for the devices.The devices are being returned for evaluation.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Product complaint #: (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: after several attempts to obtain additional information on the device status, no successful response was received.Therefore, the device is unavailable for a physical evaluation nor were pictures provided.Hence, this complaint cannot be confirmed.The information provided is not sufficient to determine a root cause for the reported failure.However, if any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, no lot numbers were supplied which precludes conducting a dhr review.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).The lot number is unknown.

• Brand Name: INTRFX ADV - SM TRIAL/DILATOR
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8182063
• MDR Text Key: 131337630
• Report Number: 1221934-2018-55776
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705026340
• UDI-Public: 10886705026340
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254828
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1