MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTFX SHEATH&SCRSYS,7.5MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2013
Type of Reportable Event	Malfunction
Additional Manufacturer 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 is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.Udi: (b)(4) ¿ incomplete.Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
It was reported by our affiliate that during the surgery, product was broken.
Additional Manufacturer 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 is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.Udi: (b)(4).Depuy synthes has been informed that the lot number is not available.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Brand Name: FEM.INTFX SHEATH&SCRSYS,7.5MM
• 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: 7654133
• Report Number: 1221934-2018-51230
• Device Sequence Number: 10794552
• Product Code: MAI
• UDI-Device Identifier: 10886705013623
• UDI-Public: 10886705013623
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 06/12/2013

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 Catalogue Number: 254681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/02/2018
• Patient Sequence Number: 1