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

Model Number 212042

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Not Applicable (3189)

Event Date 02/25/2020

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.Initial reporter phone number (b)(6).Investigation summary: according to the information provided, it was reported that when the physician asked to open the package of the quickanchor orthocord it was disassembled from the insertor and the end of the tip which is plastic was broken.The complaint device is not being returned yet, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was noticed that the anchor is off from the inserter and held in place by the suture.No structural anomalies were noticed on the anchor.In addition, the sleeve insert that is the plastic part was broken.The complaint reported was confirmed.The device was searched in the database of blind devices and it was not found, also an attempt was made in order to contact the person who sent the device, but his mailbox was full.The photo does not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), 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.Udi: (b)(4).

Event Description

It was reported by the affiliate via complaint submission tool that during a ligament hand repair surgery of the first finger of the right hand, when the physician asked to open the package of the quickanchor orthocord it was disassembled from the insertor and the end of the tip which is plastic was broken.The procedure was completed using another device.There was no patient consequence, however there was a 10 minutes surgical delay.No additional information was provided.Additional information provided by the affiliate reported the device package was not damaged and all seals were intact.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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
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> according to the information provided, it was reported that during a ligament hand repair surgery of the first finger of the right hand, when the physician asked to open the package of the quickanchor orthocord it was disassembled from the insertor and the end of the tip which is plastic was broken.No additional information was provided.The complaint device was received and inspected.It was noticed that the anchor is off the inserter but held in place by the suture.There were no structural anomalies observed on the anchor and suture.The sliding cover and suture card are in place.Finally, it was identified that one edge of the sleeve inserter was broken; possibly causing the anchor to fall off the inserter.Therefore, this complaint can be confirmed.The photo provided by the customer showed the same findings found in the physical analysis.The possible root cause can be attribute when the device might have been tapped at an off angle.However, it cannot be conclusively affirmed.A manufacturing investigation activity has been performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.As a result, the manufacturer have controls to visually inspect the device and assure that device is in good condition.There has been a closer look on the assembling and on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6)., 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.

• Brand Name: MICROQA+ W/#4OC P3
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10072967
• MDR Text Key: 207750560
• Report Number: 1221934-2020-01414
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705001880
• UDI-Public: 10886705001880
• Combination Product (y/n): N
• PMA/PMN Number: K080352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 212042
• Device Catalogue Number: 212042
• Device Lot Number: 2L82209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Date Manufacturer Received: 11/28/2020
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 163