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

Model Number 251723

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by affiliate via personal interaction that during procedure the surgeon retracted the ideal sutgrasper 60 deg ea.In closed position out of the joint, then the wire broke and was lost.The procedure was completed with 30 minute delay.No patient consequences reported.The device is available to be returned for evaluation.Additional information provided by the affiliate reported the broken wire was a part of the grasper and not the implant.It was also reported the broken wire was possibly left in the patient and additional information regarding the status of the patient could not be provided.The affiliate reported the device will not be returning for evaluation.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> according to the information provided, it was reported that the wire of the grasper broke during the procedure.The surgeon was not able to locate it in the patient's joint.The complaint device is not being returned, therefore unavailable for a physical evaluation.Since the remaining complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [5l45473] number, and no non-conformances were identified.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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [5l45473] number, and no non-conformances were identified.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9842609
• MDR Text Key: 188645748
• Report Number: 1221934-2020-00875
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251723
• Device Catalogue Number: 251723
• Device Lot Number: 5L45473
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/26/2020
• Patient Sequence Number: 1