MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFX ADVBR SCW10X30W/LGSHTH; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device is not being returned, it was implanted in the patient, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformance were identified for this part (254809) - lot number (l863005) combination as per qlik query executed 04/11/2019.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.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 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.
Event or Problem Description
It was reported that during an allograft acl reconstruction procedure the 10x30 intrafix advance screw with large sheath broke while fixating to the size 10 intrafix advance graft and inserting the anchor into the patient.The breakage caused the graft to rotate during inspection.Fragments were created and successfully removed.The case was completed with no patient harm or surgical delay.This is report 1 of 1 for (b)(4).

• Brand Name: INTRAFX ADVBR SCW10X30W/LGSHTH
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8569312
• Report Number: 1221934-2019-56957
• Device Sequence Number: 1836134
• Product Code: MAI
• UDI-Device Identifier: 10886705026685
• UDI-Public: (01)10886705026685
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160804
• 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): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 254809
• Device Catalogue Number: 254809
• Device Lot Number: L863005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1