MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 30 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	251721
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional 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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure two of the customer's ideal suture grasper 60 degrees wire tips were bent.The issue was detected once the wire hook had been released from inside the device.The case was completed with a third like-device with no patient harm or delays.The sales rep was not present for the case and could not provide any additional information.The devices are returning for evaluation.
Additional 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 is not available for physical evaluation as it has not been returned.Therefore, this complaint cannot be confirmed.Hence, the information provided is not sufficient to discern a root cause.Despite multiple attempts to obtain additional information in regards to the status of the device, no tracking number or device return availability has been provided.This complaint file is being closed, should the device be returned or any new information be received in the future, this file will be reopened at that time and updated to reflect the information received.At this 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 to monitor the extent to which this complaint is observed in the field.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7920983
• Report Number: 1221934-2018-54767
• Device Sequence Number: 1797316
• Product Code: NBH
• UDI-Device Identifier: 10886705012299
• UDI-Public: 10886705012299
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 251721
• Device Lot Number: L846765
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/28/2018
• Patient Sequence Number: 1