MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210133

Device Problem Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter phone number: (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via phone that during a cruciate ligament replacement when the two rigidfix fem 3.3 mm s/t xpin were inserted into the guide frame got jammed with the sleeve in the guide frame.The procedure was completed using milagro screws.No patient consequence and no surgical delay.No additional information was provided.Additional information received by the affiliate reported a 15 minute surgical delay but there was no known patient harm.

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.H10 additional narrative: investigation summary = the device was received and inspected.The trocar was received in jammed condition with one of the sleeve.Both devices could not be separated.The complaint can be confirmed.The second sleeve was received separately.Upon visual inspection, it was noticed that devices have nicked/scratched marks and it was discolored.A definitive root cause could not be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery) which may led them to be jammed.For scratches/nicked marks.It seems like it is due to the effort of separating the both devices.For discoloration, it is possibly due to heavy use or repeated cleaning/ sterilization cycles.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.Device history lot = a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), 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.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: 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.

• Brand Name: RIGIDFIX FEM 3.3MM S/T XPIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9850633
• MDR Text Key: 204361606
• Report Number: 1221934-2020-00907
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 210133
• Device Catalogue Number: 210133
• Device Lot Number: 6L66077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 05/04/2020
• Patient Sequence Number: 1