MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ALIGNMENT ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71674066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the side of the alignment arm broke while in use.The item was not necessary to complete the surgery.A back up device was available.No surgical delay or injury to the patient was reported.Nothing fell into the patient and all the pieces were recovered.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Per the photo attached, confirmation of a fracture is visible.A medical investigation was conducted and confirms this case reports the side of the alignment arm broke/cracked during use outside of the patient.Per email correspondence, the device was not necessary to complete the procedure.The surgery was completed without patient injury or delay.Since no patient harm is alleged, no further medical assessment is warranted.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 a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ALIGNMENT ARM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326444
• Report Number: 1020279-2021-01275
• Device Sequence Number: 793028
• Product Code: HSB
• UDI-Device Identifier: 03596010560599
• UDI-Public: 03596010560599
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71674066
• Device Catalogue Number: 71674066
• Device Lot Number: 14JSP0024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/15/2021
• 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: Hospitalization; Other; Required Intervention