MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM DETACHABLE RASP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75004644
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when the surgeon tried to remove the polar-stem detachable rasp 3, the handle did not fit the device well.It is not known how the procedure was completed.No delay was reported.
Additional Manufacturer Narrative
Results of investigation: it was reported that during procedure, when the surgeon tried to remove the polarstem detachable rasp 3, the handle did not fit the device well.It is not known how the procedure was completed.No delay was reported.The rasp which intent use is in treatment was sent back for investigation, unfortunately the mentioned unknown handle was not sent back for investigation.The rasp edges show slight signs of use.At the connection point to the handle, there are also slight bulges and signs of use.Nevertheless, there are no signs which indicate that the rasp would not work like intended.A functional test was conducted by using a regular offset adapter handle.The reported failure of an issue by removing the raps can not be confirmed.The offset adapter hold the corresponding rasp easily and the rasp can be removed from the adapter as well.The corresponding batch record for the rasp reveal no deviation which could explain the occurred failure of the device.No other complaint can be found for the corresponding batch number.In this case the failure mode cannot be confirmed and the roots cause remains undetermined.Internal complaint reference: (b)(4).

• Brand Name: POLARSTEM DETACHABLE RASP 3
• 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: 10862820
• Report Number: 9613369-2020-00244
• Device Sequence Number: 2635681
• Product Code: JDI
• UDI-Device Identifier: 07611996097511
• UDI-Public: 07611996097511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/24/2020

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: 75004644
• Device Catalogue Number: 75004644
• Device Lot Number: C64138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 12/22/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/21/2020; 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1