MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANAL REAMER 16.0MM BULLET TIP; HIP INSTRUMENTS : REAMERS

Model Number	2001-84-160
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/22/2020
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 during the reaming of the femoral canal, the surgeon complained that the 16 mm and the 16.5 mm reamers were not sharp.It took a lot of effort to get these reamers down.Surgical delay: 3 to 4 min.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received stating that there was no delay in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.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.

• Brand Name: CANAL REAMER 16.0MM BULLET TIP
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10356079
• Report Number: 1818910-2020-17350
• Device Sequence Number: 2697828
• Product Code: HTO
• UDI-Device Identifier: 10603295080541
• UDI-Public: 10603295080541
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2020

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: 2001-84-160
• Device Catalogue Number: 200184160
• Device Lot Number: SO2006291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 09/17/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/19/2020; 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1