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

Model Number	75007309
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
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 be broken.As this was noticed upon field inspection, there was not patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that a sl-plus/sbg/ipa mia offset adapter 10mm was found to be broken.A visual inspection of the returned device confirmed the stated failure mode.The release lever is fractured on the opposing side to the actuating area of the lever.The fragment was not returned for investigation.Apart from the fracture, the instrument shows signs of wear as it can be expected after repeated use over time.A review of the complaint history of the affected device was performed.No additional complaint for the batch in question was detected.For the device 75007309, one additional complaint with a comparable failure mode was reported in 2010.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The part was manufactured in 2008.The function of the complaint instrument in combination with a rasp was tested by using the respective test gauge.No deviation was detected.Hence, the functionality of the instrument is maintained despite the damage.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The release lever of the device is designed as a spring which is therefore subjected to repeated compressive forces when connecting and disconnecting the device with a broach.Previous investigations revealed that under specific circumstances, this release lever of the device may fracture during compression.The root cause is attributed to a design issue.A new design of the device has been released in order to reduce the reoccurrence of this issue.This version of the device will be monitored for similar issues.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product.No further escalation is required.Please note that 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.This version of the device will be monitored for similar issues.The returned device will be discarded.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM
• 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: 14462433
• Report Number: 9613369-2022-00261
• Device Sequence Number: 4482709
• Product Code: KWY
• 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): 06/28/2022

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: E59831
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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