MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222983

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 10/03/2019

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).Udi: (b)(4).The lot number is unknown.

Event Description

It was reported by the affiliate via email that during a cure of a foot the two strings of the gii qa+ o/c cp-2 *ea broke without using any force by surgeon.The procedure was completed using another device.No patient consequence and no surgical delay was reported.No additional information was provided.

Event Description

Additional information received from the affiliate reporting no patient consequences.It was reported patient went home and no complication occurred.The affiliate also stated the procedure was completed with the use of another anchor.

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.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: lot number.Udi: (b)(4).

Manufacturer Narrative

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 narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was a delay of an estimated time 10-15 minutes as the event required the placement of a new anchor then suturing the tendon again with the new anchor.It was reported that the threads got broken during the tightening of the suture.It was reported that there was no manual tightening.It was reported that the suture color was pink.It was reported that there were no patient consequences or impact to the user or patient.It was reported that the patient followed for right infantile cerebral hemiplegia and treatment of spasticity by regular injection of botulinum toxin.It was reported that the patient with an equine varus right foot (fdgt -10 °, fdgf + 10 °) which was an indication of aponeurotomy of the triceps sural + transfer of the tendon of the posterior tibial muscle.It was reported that the usual botulinum toxin injections will also be performed during this procedure.It was reported that a classic needle-holder has been used to suture the tendon to the anchor.It was reported that there was no suture cutter was used because the thread of anchor got broken during the tightening.

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: d4: the expiration date was documented as unknown in the initial report and has been updated as 6/30/2022.Therefore, udi: (b)(4).

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.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: after three follow ups the complaint device has not been returned.Therefore a physical evaluation cannot be performed.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).

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.Correction: h6: patient code: upon complaint review, it was determined that it was inadvertently missed on the third follow-up report that the patient code was updated to reflect that the surgery was delayed for 10 to 15 minutes.Therefore, code: 3189 (not applicable) was used to capture surgery prolonged.

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.Investigation summary: according to the information provided, it was reported that during a cure of foot bot varus equin, the 2 strands of sutures broke without any particular force applied by the surgeon.The complaint device was received and evaluated.Visual observations confirm that two sutures were found broken and were are held in place by needles.The complaint can be confirmed.The possible root cause for the reported failure can be attributed to that the instruments used in handling the suture had sharp edges or could have possibly occurred during assembly.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number: 5l29667, 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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9318771
• MDR Text Key: 207363790
• Report Number: 1221934-2019-59514
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• UDI-Public: 10886705008612
• Combination Product (y/n): N
• PMA/PMN Number: K051989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 222983
• Device Catalogue Number: 222983
• Device Lot Number: 5L29667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 11/06/2020
• Patient Sequence Number: 1