MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL SMALL HAMMER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71751135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while being used, device broke into two pieces outside patient.Procedure continued with a backup device from a competitor and no delay or injury occurred.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection the product confirmed the stated failure.The head has broken off from the shaft.The broken piece is returned with the complaint.The device was manufactured in 2014 and shows signs of significant wear/usage.A medical investigation was conducted and this case reports that the device broke during the procedure.Per complaint description, the device broke while outside of the patient.The procedure was completed using a competitor device, without any surgical delay or patient injury.Since no patient harm is alleged, no further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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: HUMERAL SMALL HAMMER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10648119
• Report Number: 1020279-2020-05238
• Device Sequence Number: 19484325
• Product Code: HSB
• UDI-Device Identifier: 03596010515469
• UDI-Public: 03596010515469
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2020

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: 71751135
• Device Catalogue Number: 71751135
• Device Lot Number: 14AST0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/01/2020
• 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