MAUDE Adverse Event Report: DEPUY MITEK LLC US PATHMAKER REPL SCREW *EA; TENDON/LIGAMENT TUNNELLER

Catalog Number	219953
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Udi:(b)(4)incomplete.The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure a piece of bone became stuck in the channel of the customer's pathmaker tunnel notcher and during clean their were unable to remove it from the device.The procedure had been completed with the device before the issue occurred with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information or a lot number for the device but stated that the device is an older device.The device will be returning for evaluation.
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.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.Investigation summary: the complaint device pathmaker along with locking screw was received and evaluated.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.It was observed that there were no anomalies found and there was no bone that was stuck which can be found from visual inspection.Hence,the complaint cannot be confirmed.Since the reported condition was not confirmed and no defect was found the root cause for the reported failure cannot be determined.No lot number was provided which precludes in conducting a manufacturing record evaluation.At this point, 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.

• Common Device Name: TENDON/LIGAMENT TUNNELLER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9350626
• Report Number: 1221934-2019-59647
• Device Sequence Number: 3231164
• Product Code: LXH
• UDI-Device Identifier: 10886705006991
• UDI-Public: 10886705006991
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 219953
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/24/2019
• Patient Sequence Number: 1