MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROQA+ W/#4OC P3; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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) ¿ incomplete.The expiration date is not currently available.
Event or Problem Description
The customer reports that the anchor broke during its placement.The surgeon used another anchor with the same code product and the same lot number to complete the surgery.Additional information response: the name of the surgeon: dr (b)(6).The nature of the procedure: proximal reinsertion of the radial collateral ligament.Date of the event: (b)(6) 2018.The delay: 5-10 minutes.Patient impact: no patient impact, all the fragments were removed from the patient.How was the procedure complete? with a new anchor.Patient data, comorbidities: latex allergy, 167 cm, 59 kg, asa level 2.Patient outcome fine.The availability of the product not available, discarded.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.These types of breakages may be due to preparation of the insertion sight prior to implantation.If the bone hole was not drilled adequately, excessive pressure may be experienced on the device wings to the point where fracture can occur.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.No non-conformance was identified for this part and lot combination.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective and preventative 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.(b)(4).The expiration date is currently unavailable.

• Brand Name: MICROQA+ W/#4OC P3
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7651005
• Report Number: 1221934-2018-52669
• Device Sequence Number: 13811226
• Product Code: HWC
• UDI-Device Identifier: 10886705001880
• UDI-Public: 10886705001880
• Combination Product (Y/N): N
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2018

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: 212042
• Device Lot Number: L680162
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018; 10/16/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/25/2018; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1