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

Model Number	75004678
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during field inspection the cs/csl/geradschaft-plus extract.Screw m6 and the polarstem extractor block were stripped and did not engage properly.No case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that during field inspection the cs/csl/geradschaft-plus extract.Screw m6 (75002165) and the polarstem extractor block (75004678) were stripped and did not engage properly.No case involved; therefore, there was no patient involvement.The device used in treatment was returned for investigation.A visual inspection was conducted.The reported failure mode could not be confirmed.No damage was observed on the thread or the rest of the device.A review of the complaint history revealed one additional complaint for the batch in question.However, a functional check confirmed that the device in scope functions as intended.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.No device problem could be identified.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.

• Brand Name: POLARSTEM EXTRACTOR BLOCK
• 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: 11793795
• Report Number: 9613369-2021-00187
• Device Sequence Number: 14420341
• Product Code: JDI
• UDI-Device Identifier: 07611996109399
• UDI-Public: 07611996109399
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 75004678
• Device Catalogue Number: 75004678
• Device Lot Number: B51349
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1