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

Model Number	75023710
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polarstem ball head impactor cracked.It is unknown when this problem was noticed.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that a polarstem modular head for 21000662 cracked.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure could be confirmed.Two distal parts of the device are broken off and were not returned.Apart from that, the device shows heavy signs of use such as scratches and gouges.Four additional complaints with batch a51136 with a similar reported failure mode were reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.However, based on the performed investigations, the relationship between the reported event and the device was confirmed.A modular head (75023711) is designed to impact a ball head on the polarstem taper.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The reported failure mode could however not be reproduced.The root cause stays undetermined after investigation.Nonetheless, in combination with our continuous effort to improve our products, further investigations started to evaluate the root cause of this failure.To date, no further corrective or preventive action are considered necessary.The returned device will be archived.B5, d1, d2, d4.
Event or Problem Description
It was reported that a polarstem modular head for 21000662 cracked.It is unknown when this was problem was noticed.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: (b)(4).

• Brand Name: POLARSTEM MODULAR HEAD FOR 21000662
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12267473
• Report Number: 9613369-2021-00337
• Device Sequence Number: 4264642
• Product Code: LXH
• UDI-Device Identifier: 07611996114386
• UDI-Public: 07611996114386
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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: 75023710
• Device Catalogue Number: 75023711
• Device Lot Number: A51136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/02/2021; 08/30/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/13/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1