MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 251723

Device Problems Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure, it was observed that the customer's ideal suture grasper 60 degree internal hook came out of the device.The case was completed with another like-device with no patient harm, but there was a five minute delay to open the new device.The sales rep was not present for the case and could not provide any additional information.The device is being returned for evaluation.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.All parts of the device were attached.The wire of the device was pressed at the distal tip.When the slider button was triggered, there was no movement of the wire.The internal components of the handle like the set screw and the spring possibly failed causing the wire to not move as intended.A non-conformance search was performed for this part, lot combination and no non-conformance's were identified.A non-conformance has been opened to investigate the issue and find the root cause.At this point in time, 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.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7956942
• MDR Text Key: 123414970
• Report Number: 1221934-2018-54933
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 251723
• Device Lot Number: L936973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1