MAUDE Adverse Event Report: DEPUY MITEK LLC US SLIDING SUTURE CUTTER

Catalog Number	214627
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The product is not being returned, it has been discarded.A lot number was supplied which indicates the device is several years old (and reportedly has seen heavy use).We cannot determine what caused the user to experience the reported event.One possible reason is the device is over 2 years old and could be considered fair wear & tear due to age and use.No corrective action is required and no further action is warranted.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 remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales rep reported his suture cutter's broke while using them in a demo.He stated the device was not used in a procedure and when he went to cut the sutures, a piece inside the device came out and the whole distal end of the device fell apart.He stated the device had seen heavy use and was visibly worn.There were no patient consequences and the device was discarded.

• Brand Name: SLIDING SUTURE CUTTER
• Common Device Name: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7788902
• Report Number: 1221934-2018-51092
• Device Sequence Number: 1188355
• Product Code: FZT
• UDI-Device Identifier: 10886705004096
• UDI-Public: 10886705004096
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/07/2013

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 214627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2013
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1