MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTRAFIXSHEATH&SCRSYS,10MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254685
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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 as it was discarded by the customer; therefore, this complaint cannot be confirmed and duplicated.The assignable root cause was not determined.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
This is report 2 of 2 for the same event.It was reported by the sales rep via phone that during an anterior cruciate ligament reconstruction procedure, it was observed that the intrafix femoral sheath and screw system 9mm devices backed out of the tunnel when the screw was being screwed in.They then used the sales rep's intrafix femoral sheath and screw system 10mm, which also backed out of the tunnel while the screw was being screwed in.Each device was removed from the patient with no debris left behind.The sales rep stated that the patient's bone quality was normal.The case was completed with a rigidfix device in the same bone hole with no patient harm or delay.The devices were discarded by the customer.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
Product complaint # (b)(6)2018 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.Device was used for treatment, not diagnosis.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.No nonconformances were identified for this part number (254685), lot number (l484075) combination.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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).Associated medwatch report number: 1221934-2018-55116.
Event or Problem Description
Additional information received from sales representative on (b)(6)2018: the patient¿s bone quality was reported as standard.The same bone hole was used to complete the procedure.The implants were removed; no debris was left in the patient.The surgeon used appropriate downward force applied with driving the screws and sheaths in.

• Brand Name: FEM.INTRAFIXSHEATH&SCRSYS,10MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8020526
• Report Number: 1221934-2018-55117
• Device Sequence Number: 1029707
• Product Code: MAI
• UDI-Device Identifier: 10886705013661
• UDI-Public: 10886705013661
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 07/31/2020
• Device Catalogue Number: 254685
• Device Lot Number: L484075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1