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	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported tat the tip of the sl-plus/sbg/ipa mia offset adapter 40mm that connects onto broach handle plate broke off while impacting.Item broke outside the patient.No injuries or surgical delays reported.Procedure was finished with an s+n backup device.
Additional Manufacturer Narrative
It was reported that the tip of the sl-plus/sbg/ipa mia offset adapter 40mm which connects onto the broach handle plate broke off while impacting.Item broke outside of the patient.No injuries or surgical delays reported.Procedure was completed with an s+n backup device.The complaint device, used in treatment, was returned for investigation.The reported failure mode could be confirmed upon visual inspection.Additionally, the instrument showed signs of use.The complaint history review was performed, no further complaints with devices of the same batch were found.The production documentation review did not find any deviations from the standard manufacturing procedure which could have contributed to the issue.Based on the conducted investigation, there are no indications that the complaint part did not meet the specifications at the time of manufacturing and the root cause could not be determined conclusively.No further actions are deemed necessary.Smith+nephew will continue to monitor for similar issues.The 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: 10394243
• Report Number: 9613369-2020-00154
• Device Sequence Number: 16659235
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 75007308
• Device Catalogue Number: 75007308
• Device Lot Number: 600921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1