MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RGDLOOP ADJUSTABLE XLARG; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	232449
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not being returned, therefore is unavailable for a physical evaluation.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the evaluation.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.Further, a review into the depuy synthes mitek complaints system revealed no similar complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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 (b)(4) 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 affiliate in (b)(6) that the lead thread on the rgdloop adjustable xlarg device broke when the surgeon attempted to insert it into the intra-articular bone hole during an anterior cruciate ligament acl reconstruction surgery.According to the reporter, the surgeon suspected that the lead thread hit the bone hole firmly at the edge of the hole.It was reported that the device was brand new and its first use when the issue occurred.There was no delay in the surgical procedure as an identical spare device was used to complete the procedure.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.

• Brand Name: RGDLOOP ADJUSTABLE XLARG
• 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: 8278182
• Report Number: 1221934-2019-56127
• Device Sequence Number: 11144854
• Product Code: MBI
• UDI-Device Identifier: 10886705024117
• UDI-Public: 10886705024117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2017

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: 12/31/2017
• Device Catalogue Number: 232449
• Device Lot Number: 3820379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1