MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP PLUS ANCHOR W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210708
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: mitek employe.Investigation summary: the complaint device was not returned by the customer after multiple attempts to retrieve the device therefore, device is not available for a physical evaluation.This complaint is not confirmed.We could not identify the complaint device with respect to its lot number since the lot numbers were not etched on the devices and the user did not specify.It is probable that the failure is not related to product design or assembly.Based on the manufacturing investigation, the manufacturing process was performed according to the process requirement and is not the root cause of this issue.Rather, the package may have been exposed to high temperature over a period of time, thus causing the plastic anchor material to soften and deform.Other than this possibility, a root cause for the user to have experienced this failure cannot be determined.The dhr review indicated that this batch of 300 devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.A review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of 300 devices that was released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, 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.Device history lot.Dhr review: part number: 210708, supplier lot number: l374611, qty.Of lot: 300, release to warehouse date: 05/11/2017, manufacturing date: 25/04/2017, expiration date: 03/31/2020, supplier: neuchatel, manufacturing site: (b)(4).No ncr, no relevance to complaint condition: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 two of the customer's lupine loop plus with orthocord were bent at the distill tip prior to a shoulder procedure.The case was completed with another like device.There were no patient consequences or delays.The devices are being returned.This is report 2 for 2 (b)(4).

• Brand Name: LUPINE LOOP PLUS ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9069660
• Report Number: 1221934-2019-58332
• Device Sequence Number: 1984537
• Product Code: MAI
• UDI-Device Identifier: 10886705001064
• UDI-Public: 10886705001064
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 210708
• Device Lot Number: L374611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1