MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 11.5 X 32; NAIL, FIXATION, BONE

Model Number	71653232
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a trauma surgery while the instrument was inside of the patient, after inserting the distal screws and confirm the rotation there was a sound.However, the surgery continued; when setting the end cap and it could not be inserted.Then, it was confirmed under image that there was a crack on the end of the meta retro fem nail 11.5 x 32 and it was removed.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
D10: added concomitant device.Case- (b)(4).
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinical information, radiograph, or the device the root cause of the reported crack cannot be determined.Per the report, the cracked meta fem nail 11.5 x 32 was removed.Based on the information provided, the procedure was successfully completed without significant delay using a smith and nephew back up device.Since there was no patient harm reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint will 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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 poor insertion technique or surgical technique.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.Additional information: d3.

• Brand Name: META RETRO FEM NAIL 11.5 X 32
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12076233
• Report Number: 1020279-2021-05461
• Device Sequence Number: 4187682
• Product Code: JDS
• UDI-Device Identifier: 03596010548412
• UDI-Public: 03596010548412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71653232
• Device Catalogue Number: 71653232
• Device Lot Number: 18HM18455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 08/18/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 06/29/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN PERI-LOC SCREW
• Outcome Attributed to Adverse Event: Required Intervention