MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75004612
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the plus sl mia dbl offset adapt.Lt 60/25mm broke no information about surgical delays or s+n backup devices was initially provided.
Additional Manufacturer Narrative
It was reported that during procedure the offset adapt.Lt 60/25mm broke.No information about surgical delays or s+n backup devices was provided.The device, intended for use in treatment, was not returned for investigation and the batch number is unknown.A product history review and a product evaluation could therefore not be performed.Hence, it is unknown to which extent the device broke.Based on the available information, the failure mode could therefore not be confirmed.S+n will continue to monitor complaints of the 60/25mm offset adapters for similar issues.The complaint will be reopened should the part be returned or should additional information be received.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4) corrected results of investigation: it was reported that during procedure the offset adapt.Lt 60/25mm broke.No information about surgical delays or s+n backup devices was provided.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.There was a fracture at the connection between the contact pin and the body of the adapter.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.This version of the device will be monitored for similar issues.The returned device will be discarded.

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10500256
• Report Number: 9613369-2020-00169
• Device Sequence Number: 3182259
• Product Code: LWJ
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2020

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: 75004612
• Device Catalogue Number: 75004612
• Device Lot Number: C53086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 12/09/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 09/28/2020; 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1