MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC PLA/PLA 2/0 PAN STR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes employee.Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for the lot number of this device.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 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.
Event or Problem Description
The sales rep reported via phone that the top hat on the customer's rapidloc implant was bent when taking it out of the package prior to a knee scope.Not likely to result in patient harm or the need for additional medical or surgical intervention.There were no patient consequences or delays.This is report 1 for 1 (b)(4).

• Brand Name: RAPIDLOC PLA/PLA 2/0 PAN STR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8991688
• Report Number: 1221934-2019-58245
• Device Sequence Number: 365392
• Product Code: MAI
• UDI-Device Identifier: 10886705010219
• UDI-Public: 10886705010219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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): 11/03/2017

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 Catalogue Number: 228320
• Device Lot Number: 3839156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1