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

Model Number	251721
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a mitek sales representative.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the distal tip of the grasping wire was bent.It is possible that the surgeon excessively leveraged the device while grasping suture under tension therefore causing the grasping wire to deform.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects identified during production that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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.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.
Event or Problem Description
It was reported that during a rotator cuff repair procedure the ideal suture grasper 30 degree tip was defective.The case was completed with another like-device with no patient harm, but a two (2) minute delay to open the new device.This report is for an ideal suture grasper 30 degree.This is report 1 of 1 for (b)(4).

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8545012
• Report Number: 1221934-2019-56924
• Device Sequence Number: 18932697
• Product Code: NBH
• UDI-Device Identifier: 10886705012299
• UDI-Public: (01)10886705012299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 05/31/2023
• Device Model Number: 251721
• Device Catalogue Number: 251721
• Device Lot Number: L909337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1