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

Model Number	75004613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the broach handle broke upon impaction.A piece fell into the patient's wound and it was successfully recovered.S+n backup device was available and no delay was recorded.
Additional Manufacturer Narrative
It was reported that a plus sl mia dbl offset adapt.Rt 60/25mm broke upon inspection.The device used in treatment, was sent back for investigation.The reported failure could be confirmed during the visual inspection.This is a known failure mode.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.The root cause for this failure will be attributed to an insufficient design.This version of the device will be monitored for similar issues.

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9738322
• Report Number: 9613369-2020-00028
• Device Sequence Number: 1815719
• Product Code: JDI
• UDI-Device Identifier: 07611996085471
• UDI-Public: 07611996085471
• 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): 05/06/2020

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 Expiration Date: 12/02/2014
• Device Model Number: 75004613
• Device Catalogue Number: 75004613
• Device Lot Number: C56217
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1