MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 STAND CUP TRIAL D38 +3MM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Model Number	2307-38-403
Medical Device Problem Codes	Use of Device Problem (1670); Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/15/2020
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.
Event or Problem Description
It was reported that the 38 poly trials are damaged with scars and missing plastic in areas surgeon and spd wanted them replaced.Protective plate is bent and won¿t sit flush on the bone.The reamers are dulled and have burrs.These items were pulled out of the sets and not used in a case.
Additional Manufacturer Narrative
Product complaint (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: STAND CUP TRIAL D38 +3MM
• Common Device Name: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10314344
• Report Number: 1818910-2020-16674
• Device Sequence Number: 11031258
• Product Code: LXH
• UDI-Device Identifier: 10603295115816
• UDI-Public: 10603295115816
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 07/15/2020

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: 2307-38-403
• Device Catalogue Number: 230738403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1