MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE A-P CHAMFER BLOCK SZ 3; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2545-00-153
Medical Device Problem Codes	Corroded (1131); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
The problem was that the metal quality was inferior and this leads to sharp metal edges in the cutting slots and even rust/corrosion formation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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.The complaint states the problem was that the metal quality was inferior and this leads to sharp metal edges in the cutting slots and even rust/corrosion formation.No devices or photos were received hence the complaint failure mode cannot be confirmed.A complaint search identified previous complaints associated with rusting/corrosion however the root cause was undetermined as no cleaning methods were provided.A complaint search identified previous complaints for 'burr/damage' and the root cause was attributed to wear out.No lot numbers were provided hence the date of manufacture of these devices is unknown.Root cause undetermined.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: ATTUNE A-P CHAMFER BLOCK SZ 3
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9871182
• Report Number: 1818910-2020-08990
• Device Sequence Number: 16871318
• Product Code: JWH
• UDI-Device Identifier: 10603295395348
• UDI-Public: 10603295395348
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/09/2020

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: 2545-00-153
• Device Catalogue Number: 254500153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1