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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the forceps did not close and the jaw would not open on the arthro grasper pen 35 up device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Udi: (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.
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.Investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (12b05), and no non-conformances were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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 to which this complaint is observed in the field.Device history lot: an mre review was performed and results were obtained as below : anomalies or discrepancies (non-conformance): none.
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 investigation summary: the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received upon visual inspection, the device was found to be worn/scratches and the laser marking on the device is slightly faded but still legible.When the trigger was actuated to test for its functionality, the upper jaw don¿t close completely; therefore, this complaint can be confirmed.The tip appeared to be slightly deform causing that the jaw and teeth did not align properly.A manufacturing record evaluation was performed for the finished device 12b05 number, and no non-conformances were identified.The lot number provided indicates this device is 9 years old and has seen considerable use in the field which is consistent with its appearance.This failure can be attributed to the wear or damaged from heavily handling.As per ifu, it is important to inspect for damage before using and functional testing.Replace a damaged, worn or bent instrument.Also, the end of useful instrument life is generally determined by wear or damage from handling or surgical use.It is necessary to follow the instructions and warnings of any cleaning and equipment used; also, the recommendation of the proper condition during the sterilization and maintenance to avoid any damage per the ifu: the device require special attention during cleaning.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12931331
• Report Number: 1221934-2021-03590
• Device Sequence Number: 19820391
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/22/2021

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: 12B05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 12/30/2021; 01/18/2022; 01/29/2022
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 12/22/2021; 12/30/2021; 01/19/2022; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown