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

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 205912690
• Report Number: 9613369-2020-00169
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1