MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP DEPTH GAUGE FOR SCREWS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75017138
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, the end of the screw depth gauge was found broken.No case or patient involved.
Additional Manufacturer Narrative
H3, h6: it was reported that the nut/end of the device is fractured.However, the account through the piece away.The remaining part, used in treatment, was returned for evaluation.The fracture cannot be confirmed, as the piece is missing.Furthermore, the returned device does not show any additional failure.The production documentation of the part was reviewed.There are no indications that the part failed to match specification at the time of manufacturing.No further complaint was reported in the past for the batch in scope.Based on the investigation, the reported failure mode cannot be confirmed, there was no further issue found.The root cause of the reported issue stays undetermined after investigation.To date, the need for further action is not indicated.Smith and nephew will monitor this device for further issues.The returned device will be discarded.

• Brand Name: POLARCUP DEPTH GAUGE FOR SCREWS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11683332
• Report Number: 9613369-2021-00156
• Device Sequence Number: 14509421
• Product Code: LPH
• UDI-Device Identifier: 07611996098556
• UDI-Public: 07611996098556
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 75017138
• Device Catalogue Number: 75017138
• Device Lot Number: A63404
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1