MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC PLA /PLA 2/0 PAN 12; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228321
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.The needle and implant attached to the suture were received unattached from each other.It was observed that the silicone sleeve of the needle was pushed back, indicating that the device had been previously used.The suture was inspected for any anomalies, and it was observed that there was a knot tied on the suture relatively far away in length from the implant.It is possible that the user did not pull the suture in a way that would properly advance the knot.However, given the information provided we cannot discern a definitive root cause for the reported failure.At this point, 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.This report is being filed 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 an unspecified surgical procedure, it was observed that when the rapdiloc was opened for use in surgery, it was observed that the thread was loose preventing its use.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: RAPIDLOC PLA /PLA 2/0 PAN 12
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9069989
• Report Number: 1221934-2019-58339
• Device Sequence Number: 3069643
• Product Code: MAI
• UDI-Device Identifier: 10886705010226
• UDI-Public: 10886705010226
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 02/29/2020
• Device Catalogue Number: 228321
• Device Lot Number: L336238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1