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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector of offset broach handle broke upon impaction.All parts recovered without issue.Delay no greater than thirty minutes was reported.Backup device was available.
Additional Manufacturer Narrative
The daa offset adapter right 60/25mm (75004613), used in treatment was received for investigation.It was reported that the connector of offset broach handle broke upon impaction.All parts could be recovered without any issues.A visual investigation could confirm this issue, the part broken off was also received for investigation.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 failure mode could be confirmed, the root cause is attributed to an insufficient design specifications.Smith and nephew will monitor this version of the device for further similar issues.The device will bi discarded.

• 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: 9568469
• Report Number: 9613369-2020-00010
• Device Sequence Number: 1814271
• Product Code: JDI
• UDI-Device Identifier: 07611996085471
• UDI-Public: 07611996085471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 75004613
• Device Catalogue Number: 75004613
• Device Lot Number: B72751
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1