MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 28MM; RECLAIM INSTRUMENTS : REAMERS

Model Number	2975-28-105
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2020
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
Reclaim hip revision (b)(6) 2020.During reaming of the proximal body the loose parts of the coloured rings were noticed.They used extra pulse lavage to decrease the risk of parts in the patient.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and visual shaved/delaminated were reviewed.It was determined visual shaved/delaminated has not caused or contributed to any deaths or serious injuries within the time period of (b)(6) 2018 ¿ (b)(6) 2022.In total, there have been zero serious injuries and zero deaths reports related to visual shaved/delaminated in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, visual shaved/delaminated associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.
Additional Manufacturer Narrative
Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and insert product experience code were reviewed.It was determined insert product experience code has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 11 2022.In total, there have been zero serious injuries and zero deaths reports related to insert product experience code in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, insert product experience code associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• Brand Name: RECLAIM PROXIMAL REAMER 28MM
• Common Device Name: RECLAIM INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11024762
• Report Number: 1818910-2020-27127
• Device Sequence Number: 981725
• Product Code: HTO
• UDI-Device Identifier: 10603295156253
• UDI-Public: 10603295156253
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2020

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: 2975-28-105
• Device Catalogue Number: 297528105
• Device Lot Number: SO2004526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 06/16/2022; 06/16/2022
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/26/2021; 07/11/2022; 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown