MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 35 UP *EA; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 214601

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure both their penetrating grasper straight and penetrating grasper 35 degree up will not open or close.The procedure was completed with another angle device with no patient harm or surgical delay to the case.The devices will be returning for evaluation.

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.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
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> according to the information provided, it was reported that during a rotator cuff repair procedure both their penetrating grasper straight and penetrating grasper 35 degree up will not open or close.The device was received and inspected visually and tested for its functionality.Visually, there are no anomalies found on the device but reveal slightly worn, used but in good condition.The device was functional tested, and can be confirming this complaint as the arthro grasper pen 35 was not open/close, the handle of the grasper making it unable to perform the intended function as it was difficult to do its functionality.The jaws do not operate as intended.The possible root cause of this type of failure can be attributed to heavy use and exerting too much pressure in operating the device which is consistent with the description provided.A manufacturing record evaluation was performed for the finished device [17p01] number, and no non-conformances were identified.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).

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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9587309
• MDR Text Key: 206746093
• Report Number: 1221934-2020-00178
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 214601
• Device Catalogue Number: 214601
• Device Lot Number: 17P01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/14/2020; 02/27/2020
• Supplement Dates FDA Received: 02/18/2020; 02/28/2020
• Patient Sequence Number: 1