MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CORTICAL FXATION FXD LOOP 20MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	232011
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(4) 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an acl reconstruction, it was observed that the leading suture of the rigidloop implant broke while the surgeon attempted to pull through the acl graft tunnels.It was reported that the surgeon was very experienced with procedure and products.The case was completed successfully with a new rigidloop and worked with no concerns.There were no fragments generated from the breakage.There was no patient consequences, but there was a two minute delay to use the new product.The implant was discarded.It was reported that the implant broke in just one place.It was reported that the patient's bone quality was good.It was reported that the surgeon/doctor was not off axis.It was reported that the same one hole was used to complete the procedure.It was reported that the implant was removed.It was reported that the color of the suture was white.It was reported that the damage/breakage occurred on mid-suture.It was reported that the suture was in contact with the instrument during breakage that wrapped around an artery clip.It was reported that a suture passer was not used in the procedure.It was reported that mitek high strength cutter was used in the surgery.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
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 additional information should become available, a supplemental medwatch will be submitted accordingly.Udi:(b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 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.

• Brand Name: CORTICAL FXATION FXD LOOP 20MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8581966
• Report Number: 1221934-2019-57011
• Device Sequence Number: 16731690
• Product Code: MBI
• UDI-Device Identifier: 10886705022656
• UDI-Public: 10886705022656
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 06/30/2021
• Device Catalogue Number: 232011
• Device Lot Number: L883034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1