MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM MODULAR HEAD FOR 21000662; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 75023710

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, the polarstem ball head impactor was gouged and chipping plastic off.As this was noticed after a tka procedure, the patient was not involved.

Manufacturer Narrative

Additional information added.

Event Description

It was reported that, a polarstem modular head for 2100066 was gouged and chipping plastic off.As this was noticed after a tka procedure, the patient was not involved.

Manufacturer Narrative

It was reported that, a polarstem modular head for 2100066 was gouged and chipping plastic off.As this was noticed after a total knee arthroplasty (tka) procedure, the patient was not involved.The device intended for use in treatment was not returned for further investigation.No visual inspection could be performed.A complaint history review was performed.The current complaint is in line with the complaint review on part level.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The review of the production documentation could not be performed due to missing batch number.A relationship between the reported events and the device cannot be confirmed.Based on the performed investigations, the failure modes of the reported issues could not be confirmed and the root cause of the reported problems remain unknown.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported events.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.Smith and nephew will continue to monitor the device for similar issues.This investigation is considered closed.

Manufacturer Narrative

H3, h6: it was reported that, a polarstem modular head for 2100066 was gouged and chipping plastic off.As this was noticed after a total knee arthroplasty procedure, the patient was not involved.The complaint device intended for use in treatment was returned for investigation.A visual evaluation of the returned device was conducted, and it was concluded that the surface of the device is heavily deformed with burrs and scratches, however, there is no visible fractures.So, the mentioned failure mode is confirmed.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The performed complaint history review for the complaint device revealed 4 additional complaints reported for the same batch.However, none of these complaints show a similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Polarstem modular head for impactor (750023711) is designed to impact a ball head on the polarstem taper.Previous investigation showed that while using the modular head as intended, the present failure mode cannot be reproduced.However, the failure mode could be reproduced by simulating an off-label use.Therefore, the root cause is attributed to an off-label use of the device.There are no indications that this failure is related to any manufacturing issues.To date, further actions are not deemed necessary.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.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.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARSTEM MODULAR HEAD FOR 21000662
• Type of Device: 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: 15244573
• MDR Text Key: 299884944
• Report Number: 9613369-2022-00471
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611996114393
• UDI-Public: 07611996114393
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75023710
• Device Catalogue Number: 75023711
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1