MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75004612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on june 7th, an offset-adapter 60 mm left 60/25 mm broke off in the broach handle so the quick connect handle is not connecting to it.It is unknown if this occurred during surgery or if there's a case involved.No injuries reported.
Additional Manufacturer Narrative
(b)(4).B4: updated event description.
Event or Problem Description
It was reported that during a tha, an offset-adapter 60 mm left 60/25 mm broke off in the broach handle so the quick connect handle is not connecting to it.The procedure was finished without delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H6: it was reported that during a total hip arthroplasty, an offset-adapter 60/25 mm left broke off in the broach handle so the quick connect handle is not connecting to it.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A complaint history review was performed.As the part was not returned for investigation, the reported failure mode could not be confirmed and a relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The root cause could not be determined conclusively and the need for corrective actions is not indicated.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition (lit.No.12.23 ed.05/16).Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor this device for similar issues.

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12043030
• Report Number: 9613369-2021-00308
• Device Sequence Number: 4000784
• Product Code: JDI
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 07/27/2021

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: 75004612
• Device Catalogue Number: 75004612
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 07/23/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/24/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1