MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED IMPACTOR - SHORT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71654554
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the short impactor tip broke off.All pieces were removed from the patient.No patient injury or other complications were reported.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection confirms the cannulated impactor ¿ short threaded tip is broken off.The broken piece was returned.The device shows significant signs of wear/usage.The device was manufactured in 2010.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: CANNULATED IMPACTOR - SHORT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9504501
• Report Number: 1020279-2019-04533
• Device Sequence Number: 2079830
• Product Code: HSB
• UDI-Device Identifier: 03596010650382
• UDI-Public: 03596010650382
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: No Information
• Device Catalogue Number: 71654554
• Device Lot Number: 10KM15805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1