MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BROACH HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71364007
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two broach handle were rusting.Since it was noticed during a field inspection, no patient was involved.
Additional Manufacturer Narrative
After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that that two broach handle were rusting.Since it was noticed during a field inspection, no patient was involved.However after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable.

• Brand Name: BROACH HANDLE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12038832
• Report Number: 1020279-2021-05272
• Device Sequence Number: 3235683
• Product Code: JDI
• UDI-Device Identifier: 03596010199232
• UDI-Public: 03596010199232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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 Expiration Date: 02/23/2011
• Device Model Number: 71364007
• Device Catalogue Number: 71364007
• Device Lot Number: 01BM07307
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1