MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRV 22.225+4; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2530-69-000
Medical Device Problem Codes	Material Twisted/Bent (2981); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During the covid period, hospital staff at (b)(6) in (b)(6) examined a variety of sets and came across several damaged instruments (7 total) in their pinnacle bantam set that require replacing: the pinnacle impactor adapter and shell trial were cross threaded and no longer usable ((b)(4)).The 28mm liner impactor was gauged (b)(4)).The articuleze trial balls and neutral trial liners were also gauged and not usable due to wear and tear ((b)(4)).All items were discarded.No patient or intra-op issues as this did not occur in the operating room.Please send replacements to the following address: (b)(6).N/c po to follow.Patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(4).By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ARTIC/EZE TR BALL GRV 22.225+4
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10053542
• Report Number: 1818910-2020-12067
• Device Sequence Number: 2848472
• Product Code: LXH
• UDI-Device Identifier: 10603295128892
• UDI-Public: 10603295128892
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 2530-69-000
• Device Catalogue Number: 253069000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1