MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM DETACHABLE RASP 01; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75023019
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure and outside the patient the polarstem detachable rasp 01.Did not connect to the broach handle.All other sizes 0-10 attached to broach handle as expected.Surgery was completed with and s+n device and was delayed for no longer than 30 min.
Additional Manufacturer Narrative
Results of investigation: it was reported that during procedure and outside the patient the polarstem detachable rasp 01 (art.No.75023019 / unknown lot no.) did not connect to the broach handle.All other sizes 0-10 attached to broach handle as expected.Surgery was completed with and s+n device and was delayed for no longer than 30 min.The complaint device, used in treatment, was not returned for investigation.The reported failure mode could not be confirmed.The lot number of the complaint device is unknown and the complaint history review and production documentation review could not be performed.Due to the insufficient information, the root cause could not be determined conclusively.Should additional information become available, the complaint investigation will be reopened.Smith+nephew will continue to monitor for similar issues.Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Investigation results: it was reported that during procedure and outside the patient the polarstem detachable rasp 01 (art.No.75023019 / lot no.B54317) did not connect to the broach handle.All other sizes 0-10 attached to broach handle as expected.Surgery was completed with and s+n device and was delayed for no longer than 30 min.The complaint device, used in treatment, was returned for investigation.The reported issue could be confirmed upon visual inspection and functional control.The device showed significant damage on the connection part and broach handle could not be attached.The complaint history review was performed for the lot number b54317.No further complaints were found for devices of the same lot.The production documentation was reviewed, there are no hints that the device did not meet the specifications at the time of manufacturing.Based on the conducted investigation, the root cause could not be determined conclusively.But it is assumed upon visual inspection of the part that the material deformation on the connection part might be caused by hits with a hammer.No further actions are deemed necessary.Smith+nephew will continue to monitor for similar issues.The device will be discarded.

• Brand Name: POLARSTEM DETACHABLE RASP 01
• 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: 10857550
• Report Number: 9613369-2020-00243
• Device Sequence Number: 19491922
• Product Code: JDI
• UDI-Device Identifier: 07611996111941
• UDI-Public: 07611996111941
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2021

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: 75023019
• Device Catalogue Number: 75023019
• Device Lot Number: B54317
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/24/2020; 03/30/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/30/2020; 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1