MAUDE Adverse Event Report: DEPUY MITEK LLC US PENETRATING GRASPER 35° UP; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	214601
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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in colombia that the penetrating grasper 35° up device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the upper jaw on the device would not open completely.There was no procedure nor patient involvement reported.No additional information was provided.
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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.E3: reporter is a j&j employee.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 information was faded.When it was actuated to test for its functionality, the upper jaw doesn¿t open completely; therefore, it was not working.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.The lot number provided indicates this device is 6 years old and has seen considerable use in the field which is consistent with its appearance.The condition of the device 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 (please review the instructions and manual cleaning in 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 synthese mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: PENETRATING GRASPER 35° UP
• 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: 17063465
• Report Number: 1221934-2023-02273
• Device Sequence Number: 20501531
• 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,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: 214601
• Device Catalogue Number: 214601
• Device Lot Number: 17R05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown