MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT 0 DEG CMT SCR TRL LNR 40MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71354298
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the instrument broke inside the patients incision.No delay was reported and a backup device was available.All the pieces were recovered.
Additional Manufacturer Narrative
The device used in treatment was returned and evaluated.A visual inspection of the returned device confirms that the instrument is broken and damaged.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part/lot revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.The plastics on the device are vulnerable and crack may have initiated during use or due to the heating and cooling associated with autoclaving.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: REDAPT 0 DEG CMT SCR TRL LNR 40MM X 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9289609
• Report Number: 1020279-2019-03918
• Device Sequence Number: 16644984
• Product Code: JDI
• UDI-Device Identifier: 00885556413449
• UDI-Public: 00885556413449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 71354298
• Device Lot Number: 16KMD0017
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1