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

Catalog Number 210133

Device Problem Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 05/23/2017

Event Type  malfunction  

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.Investigation summary: the complaint device was received and evaluated.The reported failure could be confirmed from the visible striation marks on the trocar where it had cold welded with the sleeve.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these groves then the trocar is spinning within the guide sleeve causing enough heat and friction to cause the welding of the two parts.Therefore, this type of failure has been attributed to user technique issue.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.A non-conformance search was performed to identify an non-conformance associated with this part-lot combination.No non-conformances were identified for this part-lot number (part: 210133, lot number: l188273) combination.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.(b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

The affiliate reported via email during procedure the pin stayed stuck in the sleeve during a tendon repair.No information regarding patient consequence reported to date.Additional information received via email from the affiliate on 6-7-17: it is unknown if the failure was the sleeve and trocar welded together.The procedure was completed with another rigidfix kit.The delay was less than 30 minutes.

• 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8399460
• MDR Text Key: 138106946
• Report Number: 1221934-2019-56577
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 210133
• Device Lot Number: L188273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1