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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that during a thr surgery, a piece of the spring device that allows the attachment of sl-plus/sbg/ipa mia offset adapter 10mm broke off.The procedure was completed, with a non-significant delay, using a s+n back-up device.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

It was reported that during a thr surgery, a piece of the spring device that allows the attachment of sl-plus/sbg/ipa mia offset adapter 10mm broke off.The device in question was returned for investigation.Upon visual inspection, the reported failure mode regarding the broken-off spring could be confirmed.The missing spring was not returned.A complaint history review was performed.No other complaints regarding the batch in question were found.The review of the production documentation did not detect any deviations that could have contributed to the reported failure mode.The performance of the device is within the risks, which are anticipated in the risk management documentation of the product, where the corresponding failure mode and the severity are covered.A review of past corrective actions was performed.No further escalation is required.According to the performed investigations, the relationship between the reported event and the device was confirmed.No indications that the reported device failed to meet manufacturing specifications upon release for distribution were found.The root cause for the fracture could not be identified and stays undetermined.The need for corrective action is not indicated.We remind to follow our document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19) that all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be scrapped.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM
• Type of Device: 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: 14711062
• MDR Text Key: 295416304
• Report Number: 9613369-2022-00303
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996076394
• UDI-Public: 07611996076394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75007309
• Device Catalogue Number: 75007309
• Device Lot Number: G54925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Date Device Manufactured: 05/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1