MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER DOME 54MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71362754
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a tha procedure, reamer broke during reaming the acetabulum.Delay form 30 minutes to 1 hour reported.Backup device available.No impact or injury to patient reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: REAMER DOME 54MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8839842
• Report Number: 1020279-2019-02845
• Device Sequence Number: 1400751
• Product Code: JDG
• UDI-Device Identifier: 03596010456922
• UDI-Public: 03596010456922
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2019

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 Catalogue Number: 71362754
• Device Lot Number: 10DM01826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 11/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1