MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRVD 28+15.5; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2530-85-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 several items that the central sterile department at memorial have requested to be replaced.2 femoral impactors have cracks on each notch, 28 head ball trial has a piece chipped off the skirt, i have 3 grater handles that appear to the peg in shaft missing on 2, and a warped spring on 1.The head impactor has chips on edges.I am returning each item so the damage can be viewed.Nobody was injured, i am returning all, this did not delay surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: d9 corrected: h3.

• Brand Name: ARTIC/EZE TR BALL GRVD 28+15.5
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11329915
• Report Number: 1818910-2021-03031
• Device Sequence Number: 19066065
• Product Code: HWT
• UDI-Device Identifier: 10603295128984
• UDI-Public: 10603295128984
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 2530-85-000
• Device Catalogue Number: 253085000
• Device Lot Number: DJ0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1