MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 25 DEGREES LEFT -G; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	251001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.We cannot discern a root cause for the reported failure mode.A review into the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed however, depuy 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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that the customer's ideal suture shuttle 25 degree left failed during a labrum repair surgical procedure due to the tip being dented then it cracked during the procedure and the surgeon did not think it would withstand another pass.According to the reporter, the angled shaft cracked during the procedure.Once he removed it from the joint he felt as though it cracked and would not withstand another pass.The case was completed with another like device.There were no adverse patient consequences or time delays reported.The device will not be returned as the facility discarded it.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.

• Brand Name: IDEAL SUTURE SHUTTLE 25 DEGREES LEFT -G
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8268930
• Report Number: 1221934-2018-53064
• Device Sequence Number: 19256698
• Product Code: HCF
• UDI-Device Identifier: 10886705011629
• UDI-Public: 10886705011629
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2016

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: 01/31/2020
• Device Catalogue Number: 251001
• Device Lot Number: 15J05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1