MAUDE Adverse Event Report: MEDLINE RENEWAL DEPUY MITEK; EXPRESSEW¿ III SUTURE NEEDLE

Catalog Number 214141RH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of three reprocessed depuy mitek expressew¿ iii suture needles broke off during use in an unspecified orthopedic procedure.The tips were reportedly successfully retrieved by surgeon from the surgical site.Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.It is unknown how many patients and/or procedures were involved.Due to the reported incident and the required medical intervention of retrieving the devices' broken tips from surgical site/s, this medwatch is being filed.The samples were discarded.Companion samples were returned for evaluation.The lot numbers associated with the devices were not provided.A review of the reprocessing record could not be performed.A potential root cause for the device's tip breaking is design issue (of the original equipment manufacturer).A definitive root cause for the reported issue could not be confirmed at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the reprocessed depuy mitek expressew¿ iii suture needles broke off during use.

• Brand Name: DEPUY MITEK
• Type of Device: EXPRESSEW¿ III SUTURE NEEDLE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 9142491
• MDR Text Key: 170111131
• Report Number: 3032391-2019-00023
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214141RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention