MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS REAMER SZ 12; REAMERS

Model Number	2011-01-270
Medical Device Problem Codes	Break (1069); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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
Surgeon noticed the problem on actis reamer stabilit and saw the risk of the broken reamer during surgery.Thickness of the reamer body seams are too weak even though no event happened.
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.Device history review: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS REAMER SZ 12
• Common Device Name: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11289437
• Report Number: 1818910-2021-02533
• Device Sequence Number: 3498486
• Product Code: MEH
• UDI-Device Identifier: 10603295495727
• UDI-Public: 10603295495727
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2021

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: 2011-01-270
• Device Catalogue Number: 201101270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 05/03/2021; 05/20/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/04/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1