MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER LEFT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75102237

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during a thr procedure and inside the patient, the attachment for the daa double offset adapter left 80/45 broke.Procedure was completed using the same device.No surgical delays reported.

Manufacturer Narrative

It was reported that during a total hip replacement surgery and inside the patient, the attachment of the daa double offset adapter left 80/45 broke.The procedure was completed using the same device and no surgical delays were reported.It is unclear if a part fell in the wound.The device, used in treatment, was not returned for investigation.A visual inspection could therefore not be performed.However, the batch number is known and a complaint history review could be performed.No other complaint is reported for the batch in question so far.Furthermore, a review of the production documentation did not detect any deviation from the standard manufacturing process.A medical investigation could not be performed due to insufficient information.The severity and the failure mode are covered through the smith & nephew risk management.Furthermore, the ifu (no.12.23, ed.05/16) refers to the surgical technique for the correct handling of surgical instruments.However, in this case it is unclear what may have caused the reported failure mode.To conclude, as the device has not been returned for investigation, the breakage at the clutch could not be confirmed and the root cause of the reported issue remains undetermined.The need for corrective action is not indicated.Smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

Manufacturer Narrative

Investigation results: it was reported that during a total hip replacement surgery and inside the patient, the attachment of two daa double offset adapters left 80/45 broke.The procedure was completed using the same device respectively and no surgical delays were reported.It is unclear if a part fell in the wound.The two offset adapter devices, used in treatment, were returned for investigation.Upon visual inspection, the reported failure mode could be confirmed for both devices.The clutch is broken.Apart from that, the devices show normal signs of usage such as gouges and dents.No other complaint is reported for the batch in question so far.Furthermore, a review of the production documentation did not detect any deviation from the standard manufacturing process.A medical investigation could not be performed due to insufficient information.The severity and the failure mode are covered through the smith & nephew risk management.Furthermore, the ifu (no.12.23, ed.05/16) refers to the surgical technique for the correct handling of surgical instruments.An offset adapter device 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, offset adapters may fracture during impaction.An optimized offset adapter design has been released in order to reduce the occurrence of this issue.This version of the device will be monitored for similar issues.To conclude, based on the performed investigations, the reported failure could be confirmed and the root cause is attributed to an insufficient design.Smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

• Brand Name: DAA DOUBLE OFFSET ADAPTER LEFT 80/45
• Type of Device: 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: 10841650
• MDR Text Key: 216332571
• Report Number: 9613369-2020-00236
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: B67566
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention