MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL NAIL 8/7MM X 16CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71770816
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, the surgeon had already decided to place a trigen humeral nail 8/7mm x 16cm proximal bent, but when placing it the lateral cortex broke, and he decided to place a longer one, which was 8/7mm x 24mm.No delay occurred as a consequence of this problem.Patient current health status is good.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, intake form and post-op form support the compliant, however, it does not aid in determining the clinical root cause of the reported failure.According to the report, the broken nail was removed and replaced with place a longer one, which was 8/7mm x 24mm.The provided post-op report revealed, ¿the nail was locked proximally, and distally.Excellent reduction and fixation were achieved.¿ it was reported, the patient¿s current health status is good.Therefore, since there was no delay because of this problem, no further clinical/medical assessment is warranted at this time.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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed in the preoperative planning section, that a proper type and size of implant must be selected to insure effective treatment of patients.Furthermore, fracturing of the implant components is identified as a possible adverse effect.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, intake form and post-op form support the compliant, however, it does not aid in determining the clinical root cause of the reported failure.According to the report, the broken nail was removed and replaced with place a longer one, which was 8/7mm x 24mm.The provided post-op report revealed, ¿the nail was locked proximally, and distally.Excellent reduction and fixation were achieved.¿ it was reported, the patient¿s current health status is good.Therefore, since there was no delay because of this problem, no further clinical/medical assessment is warranted at this time.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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed in the preoperative planning section, that a proper type and size of implant must be selected to insure effective treatment of patients.Furthermore, fracturing of the implant components is identified as a possible adverse effect.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H6: health effect - impact code.

• Brand Name: HUMERAL NAIL 8/7MM X 16CM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13532959
• Report Number: 1020279-2022-00694
• Device Sequence Number: 14721355
• Product Code: HSB
• UDI-Device Identifier: 03596010514387
• UDI-Public: 03596010514387
• Combination Product (Y/N): N
• PMA/510(K) Number: K032722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2022

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: 71770816
• Device Catalogue Number: 71770816
• Device Lot Number: 20LSM0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 03/17/2022; 11/29/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/20/2022; 03/23/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female