MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 ETH V-4; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212865

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2020

Event Type  malfunction  

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.(b)(4).The expiration date is unknown.

Event Description

It was reported by healthcare professional via complaint submission tool, that during a peri allnear fracture / reconstruction fdp + fdl tendon extension, while using a micro quick anchor plus preloaded with 3/0 ethibond suture and v-4 needles, surgeon drilled bone, then correctly placed anchor into bone, secured it with a few hammer blows.After this, she wanted to test the secure position of the anchor by pulling the suture as usually.The anchor was teared out.No surgical delay or patient consequence reported.

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.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.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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: investigation summary: according to the information provided, it was reported that during a peri ullnear fracture / reconstuction fdp + fdl tendon extension, while using a micro quickanchor plus preloaded, surgeon drilled bone, then correctly placed anchor into bone, secured it with a few hammer blows.After this, the anchor was teared out.The complaint device was received and evaluated.Visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture, confirming this complaint.Under magnification, the anchor revealed no structural anomalies.It was observed presence of tissue debris and blood on the suture and anchor indicating the device has been used.The distal tip of the sleeve however had one of the edges bent but held in place possibly causing the anchor to fall off the inserter.However, we cannot determine at what point in time the sleeve tip was damaged.The possible root cause can be related when the device is place into the bone and use an excessive force, it may be causing that the edges to be damaged.A manufacturing record evaluation was performed for the finished device [4l67328] number, and no non-conformances were identified.At this point, 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 lot: a manufacturing record evaluation was performed for the finished device [4l67328] 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.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was a surgical delay of 10 minutes.It was reported that there were no patient consequences or impact to the user or patient.It was reported that the case was completed with another suture anchor.It was reported that an alternative product was readily available.It was reported that there were no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).

• Brand Name: MICRO QA+ #3/0 ETH V-4
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9729895
• MDR Text Key: 200392221
• Report Number: 1221934-2020-00621
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• PMA/PMN Number: K024115
• 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: 02/07/2020

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 Model Number: 212865
• Device Catalogue Number: 212865
• Device Lot Number: 4L67328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/05/2020; 03/31/2020; 04/17/2020
• Supplement Dates FDA Received: 03/06/2020; 04/01/2020; 04/20/2020
• Patient Sequence Number: 1