MAUDE Adverse Event Report: DEPUY MITEK LLC US HIP CORDCUTTER; CUTTER, WIRE

Model Number 214138

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Occupation: initial reporter is a mitek sales representative.The complaint device was received and inspected.The complaint can be confirmed.A visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition.It was observed that the cutting end of the device was dull.To test the functionality of the device, suture was passed through the cutting end and the handle was pulled to attempt to cut the suture.The suture would not cut from this operation.It is possible that over the course of reuse of the device that the cutting end has become dull, therefore is a potential root cause for the defect observed.However, given the information provided we cannot discern a definitive root cause for the reported failure.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.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.

Event Description

It was reported that during a hip scope procedure the hip cord cutter is no longer cutting.The procedure was completed with another like device with no patient harm or surgical delay to the case.This report is for a hip cord cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Result codes, conclusion codes: upon further investigation, it was determined that the investigation result codes were operational and mechanical problems while the conclusion was that the cause was not established.Therefore, both fields have been updated accordingly to reflect the correct information.Investigation summary the complaint device was received and inspected.The complaint can be confirmed.A visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition.It was observed that the cutting end of the device was dull.To test the functionality of the device, suture was passed through the cutting end and the handle was pulled to attempt to cut the suture.The suture would not cut from this operation.It is possible that over the course of reuse of the device that the cutting end has become dull, therefore is a potential root cause for the defect observed.However, given the information provided we cannot discern a definitive root cause for the reported failure.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.

• Brand Name: HIP CORDCUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9238545
• MDR Text Key: 206759448
• Report Number: 1221934-2019-59207
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10818674021095
• UDI-Public: (01)10818674021095
• 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
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214138
• Device Catalogue Number: 214138
• Device Lot Number: 11P03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1