MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTRAFIXSHEATH&SCRSYS,9MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254684
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(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 non-conformances were identified for this part number, lot number combination per qlik query executed on 4/26/2019.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 sales rep via phone that during an acl reconstruction procedure after drilling the femoral tunnel, the screw of the femoral intrafix system was inserted into the patient and caught the outer edge of the sheath and the sheath crumbled.The sales rep stated the screw and the sheath were removed with no debris left behind.The case was completed with another like-implant in the same bone hole with no patient harm or delay.The sales rep was not present and could not provide any additional information.The implant was 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.

• Brand Name: FEM.INTRAFIXSHEATH&SCRSYS,9MM
• 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: 8591036
• Report Number: 1221934-2019-57089
• Device Sequence Number: 19406474
• Product Code: MAI
• UDI-Device Identifier: 10886705013654
• UDI-Public: 10886705013654
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 04/23/2019

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: 05/31/2020
• Device Catalogue Number: 254684
• Device Lot Number: L468266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2019
• Initial 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