MAUDE Adverse Event Report: DEPUY MITEK LLC US PENETRATING GRASPER 45° RIGHT; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	214603
Medical Device Problem Codes	Difficult to Open or Close (2921); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).The expiration date is currently unavailable.Reporter is a j&j employee.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visually, the device appears worn indicating device was heavily used; there were signs of wear on the device and the laser markings were slightly faded.Also, the jaw was loose, they were not functioning smoothly.It was observed that when the trigger of the device was pulled, the jaws would not actuate open/close consistently.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the visual results, this complaint can be confirmed.The lot number provided indicates this device is 13 years old and has seen considerable use in the field which is consistent with its appearance.This type of failure has been attributed to wear and tear as well as rough use, since the repeated excess force applied when a large amount of tissue is being grasped which cause a potential to break; also, the age of the device causing damage in the device.Other than this possibility, cannot be discerned at this point.As per ifu, inspect for damage before using.End of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.Between uses, lubricate moving parts with a water-soluble lubricant in accordance with the manufacturer¿s instructions.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in colombia that the device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the penetrating grasper 45° right device appeared worn indicating device was heavily used, had signs of wear with the laser markings slightly faded.It was further determined that the jaw was loose and was not functioning smoothly; and when the trigger of the device was pulled, the jaws would not actuate open/close consistently.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: PENETRATING GRASPER 45° RIGHT
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16069292
• Report Number: 1221934-2022-04312
• Device Sequence Number: 17707769
• Product Code: NBH
• UDI-Device Identifier: 10886705003860
• UDI-Public: 10886705003860
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 214603
• Device Catalogue Number: 214603
• Device Lot Number: 09G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2009
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown