MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75007309
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that a sl-plus/sbg/ipa mia offset adapter 10mm was found to have the tip broken off.As this was noticed upon field inspection, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that a sl-plus/sbg/ipa mia offset adapter 10mm was found to have the tip broken off.As this was noticed upon field inspection, there was no patient involvement.The complaint device, which intent use is treatment, was returned for investigation.The reported issue was confirmed upon visual inspection, the tip of the instrument is fractured.A complaint history review showed no further complaints of devices from the same batch.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure and a material analysis confirmed the specification of the material.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The failure mode and the severity are covered in the corresponding risk management file.A review of past corrective actions was performed.No further escalation is required.A relationship between the reported event and the device could be confirmed.Based on the performed investigations, the probable cause could not be determined.As this instrument was produced in 2010, normal wear and tear through repeated use is known to contribute 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.No further actions are deemed necessary.This version of the device will be monitored for similar issues.This investigation is considered closed.The complaint device will be retained.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM
• 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: 12599248
• Report Number: 9613369-2021-00381
• Device Sequence Number: 14520673
• Product Code: JDI
• UDI-Device Identifier: 07611996076394
• UDI-Public: 07611996076394
• Combination Product (Y/N): N
• 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): 12/24/2021

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: 75007309
• Device Catalogue Number: 75007309
• Device Lot Number: F70955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2010
• 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