MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN EXPRESSEW NEEDLE; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number UNKNOWN

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

It was reported that the grip did not come back when pushed the grip to the end with the needle loaded in the reported device during rotator cuff repair surgery on (b)(6) 2018.It was brand new and the first use when the issue occurred.There was 10 min delay in surgery and no harm to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.The product is an unknown expressew product, therefore we cannot discern a potential root cause for the reported failure at this time.Furthermore, no lot numbers were supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.If any additional information is obtained, this complaint will be re-opened to capture that information.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 with which this complaint is observed in the field.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number are not available.Associated medwatch report number: 1221934-2018-50381.

• Brand Name: UNKNOWN EXPRESSEW NEEDLE
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7383515
• MDR Text Key: 104145753
• Report Number: 1221934-2018-50380
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1