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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
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.Apart from (b)(4) including two devices, no additional complaint with batch b67566 was reported so far.Furthermore, a review of the production documentation did not detect any deviation from the standard manufacturing process.Upon medical investigation, a backup device was used to complete the procedure.Correspondence confirmed that all pieces were recovered and no surgical delay or patient harm was reported.Since there was no report of retained foreign body, patient injury, or surgical delay and the procedure was reportedly successfully completed, no further medical assessment is warranted at this time.The severity and the failure mode are covered through the smith & nephew risk management.Furthermore, the ifu ((b)(4)) 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
• 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: 11684518
• Report Number: 9613369-2021-00157
• Device Sequence Number: 19606801
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: B67566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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: Hospitalization; Other; Required Intervention