MAUDE Adverse Event Report: DEPUY MITEK LLC US GRAVITY TUBE SET 24PK; 1113 GRAVITY TUBE SET PK/24 -SH

Model Number	281113
Medical Device Problem Codes	Filling Problem (1233); Overfill (2404)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
Fill chamber overfilled knee scope.No delay.No patient harm.Used another unit to complete the surgery.New unit to (b)(6) in biomed.
Additional 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.¿ investigation summary: 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
Fill chamber overfilled knee scope.No delay.No patient harm.Used another unit to complete the surgery.New unit to (b)(6) in biomed.Additional information received on 2/15/2018: there was no visible lot number on the device due to its age, also the device was discarded by the account and will not be coming back.

• Brand Name: GRAVITY TUBE SET 24PK
• Common Device Name: 1113 GRAVITY TUBE SET PK/24 -SH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7133068
• Report Number: 1221934-2017-50084
• Device Sequence Number: 10784698
• Product Code: HRX
• UDI-Device Identifier: 10886705015856
• UDI-Public: 10886705015856
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017
• Report Date (Section F): 11/20/2017

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 Model Number: 281113
• Device Catalogue Number: 281113
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1