MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	232011
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.No nonconformances were identified for this part-lot number combination.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.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
Device report from (b)(6) reports an event as follows: it was reported that during a surgery, the sutures of the cortical fixation fixed loop could not get through the femoral tunnel.The surgeon confirmed that the hole for the leading suture on the button was off to the center.The surgeon put the suture again and the surgery was completed successfully.The surgery was delayed by less than 30 minutes.There was no adverse consequence to the patient.This report is for a cortical fixation fxd loop 20mm.This is report 1 of 1 for (b)(4).

• Brand Name: RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8744284
• Report Number: 1221934-2019-57459
• Device Sequence Number: 1342069
• Product Code: MBI
• UDI-Device Identifier: 10886705022656
• UDI-Public: (01)10886705022656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 232011
• Device Catalogue Number: 232011
• Device Lot Number: L846881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1