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	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Event or Problem Description
It was reported that during a thr the handle of a sl-plus/sbg/ipa mia offset adapter 40mm broke.Procedure was completed with a smith and nephew backup device, no delay reported.No patient harm reported.
Event or Problem Description
It was reported that during a thr the handle of a sl-plus/sbg/ipa mia offset adapter 40mm broke.Procedure was completed with a smith and nephew backup device, no delay reported.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during a thr the handle of a sl-plus/sbg/ipa mia offset adapter 40mm broke.The device, used in treatment, was returned for investigation.Upon visual inspection, the fracture at the connection between the contact pin and the body of the adapter could be confirmed.Apart from that, the device shows normal signs of usage such as small dents and scratches.A review of the production documentation did not reveal any deviation from the standard operating procedure.No additional complaint with the batch in question was reported so far.The severity and the failure mode are covered through the smith & nephew risk management.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.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", all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Furthermore, instruments should only be used in their original condition.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 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
• MDR Report Key: 12431066
• Report Number: 9613369-2021-00355
• Device Sequence Number: 3516646
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: H62158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/06/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention