MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 90 DEGREES; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number 251005

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by affiliate via personal interaction that during arthroscopic rotator cuff repair the ideal suture shuttle 90 degrees became distorted on its tip under normal usage.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.Additional information received from the affiliate reported the case was completed but could not provide additional details.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that the suture shuttle was distorted on the tip during the procedure.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the 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 [19b07] 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 [19b07] number, and no non-conformances were identified.

• Brand Name: IDEAL SUTURE SHUTTLE 90 DEGREES
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9849609
• MDR Text Key: 207947159
• Report Number: 1221934-2020-00901
• Device Sequence Number: 1
• Product Code: HCF
• UDI-Device Identifier: 10886705011667
• UDI-Public: 10886705011667
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 251005
• Device Catalogue Number: 251005
• Device Lot Number: 19B07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1