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

Catalog Number 210133

Device Problems Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.

Event Description

It was reported by the affiliate via cst that the rigidfix fem 3.3 mm has been rejected by the patient.It had to be removed through the popliteal muscle causing a scar in that area.Additional information received from the affiliate reported the lot number is unknown and the procedure occurred about 2 months ago.The affiliate also reported the events reported did not occur during the procedure but some time after.

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was inadvertently returned to the depuy spine customer quality group.Upon receipt, the returned device looked like it may be a fragment of a spine product, and the depuy spine engineer proceeded to autoclave the device.The autoclaving process caused the returned device to break into multiple pieces, and it was determined at that point that the device was actually a depuy mitek product.No investigation of the physical device is now possible, however a photo provided of the complaint device at the customer is available for a visual inspection.The photo revealed the device was bent / deformed, not straight as it should be.It is possible the device was damaged during the migration in the patient, or during the removal process from the patient.Hence,the complaint can be confirmed.It is unlikely the device was in the condition observed in the photo at the time it was placed in the patient as it would have been noticeable to the surgeon.No lot number was provided which precludes the ability to conduct a device history record review.We cannot determine a root cause for the reported failure.At this point, 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).The lot number is unknown.

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.

• 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: 8793315
• MDR Text Key: 151123621
• Report Number: 1221934-2019-57669
• 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,Followup
• Report Date: 06/17/2019

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 Catalogue Number: 210133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 08/07/2019; 09/13/2019; 09/13/2019
• Supplement Dates FDA Received: 09/05/2019; 09/13/2019; 09/18/2019
• Patient Sequence Number: 1