MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER/ROTCUFF INSERT *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number 212114

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (1809001), 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.

Event Description

It was reported by the sales rep that during a biceps tenidosis, it was observed that the tip of the inserter super/rc was bent and broke off when inserting the anchor into the patient´s body.The anchor was successfully implanted using the same device.All fragments were retrieved from the patient.No patient consequences or procedure delay reported.No additional information was provided.

• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10339444
• MDR Text Key: 200837491
• Report Number: 1221934-2020-01950
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705001927
• UDI-Public: 10886705001927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212114
• Device Catalogue Number: 212114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1