MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75004613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during total hip replacement, a plus sl-plus mia dbl offset adapt.Right 60/25mm broke on impaction, inside the patient.All parts were retrieved by hand.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that, during total hip replacement surgery, a plus sl-plus mia dbl offset adapt.Right 60/25mm broke on impaction, inside the patient.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The clutch is broken.Apart from that, the device shows normal signs of usage such as gouges and dents.A complaint history review was performed.One additional complaint with the batch in scope was reported so far.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Upon performed medical investigation, no patient injuries or adverse consequences were reported.Therefore, no further clinical/medical assessment is warranted at this time.The failure mode and the severity are covered in the corresponding risk management document.A review of past corrective actions was performed.No further escalation is required.However, based on the performed investigations, the relationship between the reported event and the device was confirmed.This instrument is designed to hold and guide the detachable rasps for broaching.It is therefore subjected to repeated impact forces via the modular knock plate or the pneumatic woodpecker.Previous investigations demonstrated, that under specific circumstances, this device may fracture during impaction.An optimized design of the device has been released in order to reduce the occurrence of this issue.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.This version of the device will be monitored for similar issues.The returned device will be discarded.

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 13054835
• Report Number: 9613369-2021-00425
• Device Sequence Number: 3951370
• Product Code: KWY
• UDI-Device Identifier: 07611996085471
• UDI-Public: 07611996085471
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• 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
• Report Date (Section B): 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75004613
• Device Catalogue Number: 75004613
• Device Lot Number: B51295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown