MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-8MM SHEATH TRIAL; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.The lot number is currently unavailable evaluation statement: the complaint device was received and evaluated.Visual observation confirms the weld breakage reported as the sheath end is completely separated from the t-handle on the device.The device also exhibits wear as would be typical with excessive abuse of the device over repeated uses.This excessive abuse would be typical of the separation of the two ends from each other as is noted in this complaint.It was noted that the design of this device was changed making it a single piece design, thus eliminating the weld.Therefore, it can be determined that this design change has corrected the separation failure mode.Furthermore, no lot numbers were provided which precludes conducting a batch history review or a lot specific search in the complaints handling system.Based on the overall complaint rate and implemented design changes, at this point in time, 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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during a demonstration, it was observed that the biointrafix 7-8mm sheath trial device broke into two pieces; and that a guide wire could not pass through the modular driver.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BIOINTRAFIX 7-8MM SHEATH TRIAL
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8257921
• Report Number: 1221934-2018-54097
• Device Sequence Number: 1833113
• Product Code: LXH
• UDI-Device Identifier: 10886705013418
• UDI-Public: 10886705013418
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1