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

Model Number	71654554
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure the cannulated impactor - short broke while impacting a tibia nail.This happened during use inside the patient.No delay to procedure.A s&n back up was available to complete the procedure.Any other issue that could affect the patient's condition was not reported by this event.Information was reviewed.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.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 2016.A medical investigation was conducted and per complaint details, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.The product evaluation and a single photo provided, confirmed the device and the broken piece returned.Additionally, the product evaluation confirmed there were no manufacturing deviations that could have led or contributed to the reported incident.Therefore, since there was no reported delay or harm to the patient and an smith and nephew back up was available to complete the procedure; no further clinical/medical assessment is warranted at this time.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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: CANNULATED IMPACTOR - SHORT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382526
• Report Number: 1020279-2020-03801
• Device Sequence Number: 11650611
• Product Code: HSB
• UDI-Device Identifier: 03596010650382
• UDI-Public: 03596010650382
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71654554
• Device Catalogue Number: 71654554
• Device Lot Number: 16AM16217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention