MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 22/45; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75000652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polarcup trial insert slotted 22/45 is chipped.As this was noticed in a non-surgical environment, there was not any patient involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that a polarcup trial insert slotted 22/45 is chipped.As this was noticed in a non-surgical environment, there was not any patient involved.The complaint device, used in treatment, was not returned for investigation.The reported issue could not be confirmed upon visual inspection of the complaint device.The lot number of the complaint part was not provided hence the production documentation could not be reviewed.The complaint history review was performed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.There are not any indications that the device did not meet the specifications at the time of manufacturing.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should the device be received.
Additional Manufacturer Narrative
H3, h6: it was reported that a polarcup trial insert slotted 22/45 is chipped.As this was noticed in a non-surgical environment, there was not any patient involved.The complaint device, used in treatment, was not returned for investigation.The reported issue could not be confirmed upon visual inspection of the complaint device.The lot number of the complaint part was not provided hence the production documentation could not be reviewed.The complaint history review was performed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.There are not any indications that the device did not meet the specifications at the time of manufacturing.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should the device be received.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the corrugated tubing was torn.A device history record (dhr) review was performed on the lot number of the sample received and there were no issues found that could relate to the reported complaint.Based on the visual exam, the reported complaint was confirmed.The manufacturing site reports "the tubing of the device was supplied by our supplier." a non-conformance was opened to address this issue.

• Brand Name: POLARCUP TRIAL INSERT SLOTTED 22/45
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13532791
• Report Number: 9613369-2022-00030
• Device Sequence Number: 19843386
• Product Code: LXH
• UDI-Device Identifier: 07611996116663
• UDI-Public: 07611996116663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 75000652
• Device Catalogue Number: 75000652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 03/21/2022; 03/21/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/22/2022; 03/23/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown