MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CRUCIATE+ GUIDE CARRIAGE; LIGAMENT RECONSTRUCTION INSTRUMENT SET

Catalog Number	219001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the device was received and evaluated.Visual inspection confirms that the thumb depressor is stuck.The device was returned to the manufacturer for evaluation.The part was disassembled.At that time, it was determined that one feature fell out of tolerance preventing normal functional requirements.The true position of the wedge slot prevented the device from functioning properly.This complaint can be confirmed.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed a similar complaint for this lot released to distribution, which has been escalated to a non-conformance to document and monitor this failure.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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep that upon receipt, it was observed that the thumb depressor on the their cruciate + tibial capture device got stuck while it was being pushed into the cruciate + guide carriage device.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.
Additional 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.Correction: device manufacture date: the device manufacture date was inadvertently missed in the initial report and has been updated as 7/25/2017.If additional information should become available, a supplemental medwatch will be submitted accordingly.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Brand Name: CRUCIATE+ GUIDE CARRIAGE
• Common Device Name: LIGAMENT RECONSTRUCTION INSTRUMENT SET
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8281424
• Report Number: 1221934-2018-55389
• Device Sequence Number: 2418577
• Product Code: LXH
• UDI-Device Identifier: 10886705025848
• UDI-Public: 10886705025848
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: 219001
• Device Lot Number: 1707001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1