MAUDE Adverse Event Report: DEPUY MITEK LLC US HIP BITER STRAIGHT EXPRESSEW III SUTURE PASSER W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 214140

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

This is report 1 of 2 for (b)(4).It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the expressew iii suture passer w/o hook device was no longer functioning property as it has broken jaws.During in-house engineering evaluation, it was determined that the jaw was not broken but it was loose.According to the evaluation, when the trigger was fully depressed, the jaw could not be closed completely.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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).Initial reporter is a j&j sales representative.The expiration date and device manufacture date are currently unavailable.Investigation summary: the complaint device was received and evaluated.Upon visual inspection, it could be observed that the device has some marks of use as usual on these type of reusable devices.The device does not show any structural anomalies.The jaw is not broken, however it is loose.When the trigger was fully depressed, the jaw cannot be closed completely.Due to the condition of the jaw, the functional test cannot be performed.A manufacturing record evaluation was performed for the finished device 38202-160707-01 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the loose jaw condition can be attributed to procedural variables, such handling of the device or product interaction during procedure, a bigger portion of tissue may have been grabbed and forced the jaw to close, also, since this device is reusable, the continuous use and sterilization process can cause metal fatigue leading to a non-closing jaw, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: HIP BITER STRAIGHT EXPRESSEW III SUTURE PASSER W/O HOOK
• Type of Device: 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: 15450458
• MDR Text Key: 306255635
• Report Number: 1221934-2022-02863
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: 10886705020218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214140
• Device Catalogue Number: 214140
• Device Lot Number: 38202-160707-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1