MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75007308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during thr surgery, a sl-plus/sbg/ipa mia offset adapter 40mm broke.The bolt fell inside the patient's anatomy and was retrieved by the surgeon.Surgery was resumed, without any delay, with a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that during total hip replacement surgery, a sl-plus/sbg/ipa mia offset adapter 40mm broke.The bolt fell inside the patient's anatomy and was retrieved by the surgeon.Patient was not harmed as consequence of this problem.The complaint device used in treatment was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the proximal clutch is fractured and no parts appear to be missing.The main body of the complaint sample as well as the broken-off piece were returned.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed (1) one similar complaint reported for the same batch, and three additional similar complaints for the same product number over the past 12 months with 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.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.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 further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device/these devices for similar issues.The returned device will be discarded.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16728318
• Report Number: 9613369-2023-00136
• Device Sequence Number: 6700364
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• 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
• Report Date (Section B): 05/18/2023

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: 75007308
• Device Catalogue Number: 75007308
• Device Lot Number: H62409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown