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

Model Number	214601
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).
Event or Problem Description
It was reported by sales rep via complaint submission tool as follows: contact by cssd staff informing me that the penetrating grasper 214601 from their rcr extras consignment tray is not opening or closing.Upon closer inspection, the instrument is missing a screw.See attached photo.No patient consequences or surgical delay reported.The device is available for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary: according to the information provided, it was reported that the penetrating grasper 214601 from their rcr extras consignment tray is not opening or closing.Upon closer inspection, the instrument is missing a screw.¿ the device was received and evaluated.Visually, the device appears worn indicating device was heavily used due to it had a lot of marks of wear.The screw was missing from the handle making which cause unable to perform the function as normally.Also, the jaws were loose, they were not functioning smoothly.The photo provided by the customer showed the same condition found during the physical analysis.Therefore, this complaint can be confirmed.Lot number on the device indicates this device is 10 years old and hence this failure can be attributed to normal field wear.This type of failure has been attributed to wear and tear as well as rough use, since the repeated excess force applied to operate the device and age of the device causing damage in the device.Other than this possibility, cannot be discerned at this point.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required. 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).

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10810621
• Report Number: 1221934-2020-03375
• Device Sequence Number: 3798882
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2020

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: 214601
• Device Catalogue Number: 214601
• Device Lot Number: 10R01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 12/14/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/11/2020; 12/14/2020
• Patient Sequence Number: 1