MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 12-15; PRSTHESIS, HIP, SEM-CNSTRIND, MTL/CRMIC/PLYMR, CMNTD OR NON-PRUS,UNCMNTD

Catalog Number	71354631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery device broke inside the patient, all pieces were recovered.The procedure was successfully completed without delay using an s&n back-up device.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure modes.The wave springs were missing from the trial body, rendering it inoperable.A small section of the plastic tip of the impactor fractured off and was not returned.The devices were manufactured in 2015 and show signs of extensive wear / usage.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REDAPT TRIAL BODY SZ 12-15
• Common Device Name: PRSTHESIS, HIP, SEM-CNSTRIND, MTL/CRMIC/PLYMR, CMNTD OR NON-PRUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9446625
• Report Number: 1020279-2019-04355
• Device Sequence Number: 16705053
• Product Code: LZO
• UDI-Device Identifier: 00885556578605
• UDI-Public: 00885556578605
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• 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): 01/16/2020

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: 71354631
• Device Lot Number: 15MPG0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1