MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFX CRVE ST ACL PLA XPIN SYS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 213013

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that the rigidfix curve soft tissue acl cross pin system drill parts broke off.The sleeve could not be placed properly due to this issue.The sleeve and the drill sealed together due to the speed of the drill.There was no harm to the patient, but there was a four minute surgical delay.Additional information provided by the affiliate reported that the event occurred during a knee vkb and the case was completed with a new readily available implant.The affiliate also reported there is no surgical intervention planned and it was unknown if a new bone hole was utilized to complete the procedure.It was also reported that small pieces of the drill did break off but all parts were removed and nothing remained in the patient.

Manufacturer Narrative

Product complaint # (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Nr was identified for this part number, lot number per qlik query executed on 5/28/2019.The complaint condition is unrelated to the nonconformance.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.Udi: (b)(4).

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8668014
• MDR Text Key: 147950776
• Report Number: 1221934-2019-57302
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K130105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 213013
• Device Lot Number: L909499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Patient Sequence Number: 1