MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL NAIL CAP SET SCREW 0MM; NAIL, FIXATION, BONE

Model Number	71656000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the meta-nail cap set screw 0mm was placed and it broke at the head of the plug, remaining inside the intramedullary nail, it was possible to extract a part of the fragment of the plug.The device was located inside the patient at the moment of the issue.The procedure was able to be completed with the same device.Surgery was less than or equal to 30 mins delayed.The patient was not harmed beyond the reported problem.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the clinical/medical investigation concluded that, the case reports the breakage of the meta-nailscrew 0mm at head of the plug during the placement.Two undated, unlabeled fluoroscopic images were provided.One fluoroscopic image shows a driver inside of the meta-nail cap set screw at the head of the plug.According to the report, it was possible to extract only a part of the fragment of the plug with forceps and the remainder was left inside of the intramedullary nail.The second image confirms a broken piece is retained at the head of plug inside of the intramedullary nail.As these were intraoperative images it cannot be confirmed the final state of the pieces.Based on the information provided, the definitive clinical root cause of the reported failure could not be determined.Although, we cannot rule a procedural vs user error as a likely contributory factor.Per the report, the surgeon was able to complete the procedure with the same device with a less than or equal to 30-minute surgical delay.Since it was reported, the patient was not harmed beyond the reported problem, and no further impact is anticipated, no further clinical/medical assessment is warranted at this time.A review of the production order 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 instructions for use documents for knee systems revealed that fracture of the implant can occur as a result of improper alignment.It also revealed in warnings and precautions in the intraoperative section that failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include, surgical technique used or user/procedural variance.As the device broke and caused a delay, the contribution of the device to the reported event could be corroborated.Based on this investigation, the need for corrective action is not indicated.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.
Event or Problem Description
It was reported that the meta-nail nail cap set screw 0mm was placed and it broke at the head of the plug, remaining inside the intramedullary nail, it was possible to extract a part of the fragment of the plug with forceps.The device was located inside the patient at the moment of the issue.The procedure was able to be completed with the same device.Surgery was less than or equal to 30mins delayed.The patient was not harmed beyond the reported problem.

• Brand Name: META-NAIL NAIL CAP SET SCREW 0MM
• Common Device Name: NAIL, FIXATION, BONE
• 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: 15870186
• Report Number: 1020279-2022-04826
• Device Sequence Number: 5258432
• Product Code: JDS
• UDI-Device Identifier: 03596010585417
• UDI-Public: 03596010585417
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

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: 71656000
• Device Catalogue Number: 71656000
• Device Lot Number: 22CM23452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 12/21/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 11/30/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: Other
• Patient Age: 18 YR
• Patient Sex: Male