MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 11.5 X 42; NAIL, FIXATION, BONE

Model Number	71653242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during trauma surgery, while inserting the retrograde nail, the surgeons came upon some difficulties with the proximal end of the nail; namely with the threading and the metal nail jig attachment.Initial entry was made through the base of the knee with the threaded guide pin after which the canal was reamed up to 13mm to facilitate an 11.5mm nail.The ruler was then used to measure the length of the nail needed and the decision was made to use an 11.5mm x 42mm nail.Next, the meta-nail attachment was secured to the sterile nail for insertion.Upon entry into the canal complaints were made about the meta nail attachment becoming loose while trying to pass the nail which ultimately resulted in the bolt detaching and failing out whereafter the nail was essentially mangled with a piece breaking off.Afterwards, intraoperative screening revealed a narrow intramedullary canal.Subsequently there were major difficulties in trying to remove the damaged nail.The team employed the use of the hospital¿s wire cutter which they have asked to be replaced, a vice grip, steinmann pins and large nibblers to no avail.The choice was ultimately made to resort to a osteotomy to impact the nail out which was successful in carrying out the removal.They then opted to insert 10mmx42mm nail after the removal of the damaged one.Additionally, after the team¿s investigation of the nails¿ packaging, it was realized that they were manufactured in tennessee and germany respectively which they have insisted is the reason for the difference in quality of the nails.A delay was reported, but is not known if it was significant.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that based on the information provided, a procedural variance/user error cannot be ruled as the likely cause of the reported failure.According to the report, the surgeon used a change in the surgical technique to complete the procedure.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.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 instructions for use documents for intramedullary nail system revealed that fracture of the implant components has been identified as a possible adverse effect.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to surgical technique used or user/procedural variance.The contribution of the device to the reported incident could be corroborated as the device was damaged during use and caused a delay in surgery.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.

• Brand Name: META RETRO FEM NAIL 11.5 X 42
• 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: 14364770
• Report Number: 1020279-2022-02324
• Device Sequence Number: 5622058
• Product Code: JDS
• UDI-Device Identifier: 03596010548467
• UDI-Public: 03596010548467
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• PMA/510(K) Number: K051557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71653242
• Device Catalogue Number: 71653242
• Device Lot Number: 21EM02853
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown