MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ #2-0 OC RB-1; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212854

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 03/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Udi: (b)(4).

Event Description

It was reported by the sales rep via complaint submission tool that when doing a scapholunate reconstruction the surgeon used a minilok qa+ #2-0 oc rb-1 and after inserting the anchor and testing it, it pulled out the bone and the surgeon did this for three times without success.The procedure was completed using a device from another company.There was no patient consequence, however there was a 5 minutes surgical delay reported.No additional information was provided.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: correction: d4, h4: the lot number, expiration date and device manufacture date have been updated accordingly to reflect the correct information.Therefore, udi: (01)(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary : the device was received and inspected.Visual observations reveal the anchor was received separately from the inserter but held in place by the suture, as device was used in surgery.Upon further observation, no anomalies were noted on the anchor.However, the pin on distal end of the inserter tip was found to be bent.It could be possible that the bent condition can cause the reported failure.The complaint can be confirmed.Although a definite root cause cannot be determined, it is a possibility that excess torque was applied when inserting the anchor at off angle which caused the inserter tip to bend.A manufacturing record evaluation was performed for the finished device [1l76605] number, 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.Device history review : a manufacturing record evaluation was performed for the finished device [1l76605] number, and no non-conformances were identified.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: b3: the date of event has been updated to reflect the information.B5: subsequent follow-up with the customer, additional information was received.It was reported that the user amy use another device going forwards.It was reported that the surgeon was able to use the same drill hole for the replacement device.

• Brand Name: MINILOK QA+ #2-0 OC RB-1
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9861456
• MDR Text Key: 207748790
• Report Number: 1221934-2020-00935
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002436
• UDI-Public: 10886705002436
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 212854
• Device Catalogue Number: 212854
• Device Lot Number: 1L76605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/22/2020; 04/13/2020; 05/11/2020
• Supplement Dates FDA Received: 03/23/2020; 04/14/2020; 05/12/2020
• Patient Sequence Number: 1