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

Model Number	214600
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Udi: (b)(4).
Event or Problem Description
It was reported via complaint submission tool that during a shoulder repair, the surgeon was using the penetrating grasper straight to pass suture through the rotator cuff.He tried to open the jaws, heard a pop, and the jaws would not open.Upon investigation, the jaws would not open any longer.The instrument was replaced with a readily available replacement and the case was successfully completed without patient harm or surgical delay.
Additional 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.H10 additional narrative: correction: d10: the date device returned to manufacturer has been updated to reflect the correct information.Investigation summary: according to the information provided, it was reported via complaint submission tool that during a shoulder repair, the surgeon was using the penetrating grasper straight to pass suture through the rotator cuff.He tried to open the jaws, heard a pop, and the jaws would not open.Upon investigation, the jaws would not open any longer.The instrument was replaced with a readily available replacement and the case was successfully completed without patient harm or surgical delay.The device was received and inspected.Visual inspection reveals that the device lot number 19e05, not presented physical damages or deformations in the handle or shaft.The device was tested, as a result, the jaws do not open or close.Therefore, the mechanism to close and open the jaws was defective.This complaint can be confirmed.The possible root cause for the reported failure could be related to fair wear and tear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:19e05, 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.
Additional 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.Correction: d10: the date device returned to manufacturer has been updated to reflect the correct information.Investigation summary : according to the information provided, it was reported via complaint submission tool that during a shoulder repair, the surgeon was using the penetrating grasper straight to pass suture through the rotator cuff.He tried to open the jaws, heard a pop, and the jaws would not open.Upon investigation, the jaws would not open any longer.The instrument was replaced with a readily available replacement and the case was successfully completed without patient harm or surgical delay.The device was received and inspected.Visual inspection reveals that the device lot number 19e05, not presented physical damages or deformations in the handle or shaft.The device was tested, as a result, the jaws do not open or close.Therefore, the mechanism to close and open the jaws was defective.This complaint can be confirmed.The possible root cause for the reported failure could be related to fair wear and tear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:19e05, 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.Device history lot : a manufacturing record evaluation was performed for the finished device [19e05] number, and no non-conformances were identified.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10652824
• Report Number: 1221934-2020-02923
• Device Sequence Number: 3282082
• Product Code: NBH
• UDI-Device Identifier: 10886705003839
• UDI-Public: 10886705003839
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 214600
• Device Catalogue Number: 214600
• Device Lot Number: 19E05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 10/13/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/13/2020; 10/13/2020
• Patient Sequence Number: 1