MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210711

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was implanted in the patient, 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 (4l53258), and no non-conformance was 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.Initial reporter phone number (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that the lupine anchor suture broken off anchor when inserting.Anchor left in patient but suture taken out.Added 5 mins to surgery time.No adverse outcome expected.Additional information provided by the affiliate reported the procedure was completed by using more lupine anchors and the surgeon was not concerned about the anchors remaining in the patient since they are bio-absorable.

• Brand Name: LUPINE BR W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10550312
• MDR Text Key: 207509679
• Report Number: 1221934-2020-02657
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001095
• UDI-Public: 10886705001095
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 210711
• Device Catalogue Number: 210711
• Device Lot Number: 4L53258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1