MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 11.5 X 36 130 D TAN LT LIME; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71647336
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4) h7: the field safety corrective action r-2023-06 has been initiated on 24-jul-2023 to voluntarily remove two batches of the trigen trochanteric antegrade nail (21ksm0598 & 21ksm0606).This action was taken in response to a packaging error that was reported through (b)(4).Once the fda recall number is made available to smith+nephew, it will be included in the following mdr reports.
Event or Problem Description
It was reported that, during an internal fixation procedure, while installing the 11.5 x 36 130 d tan lt lime on a targeter, it was noticed it had a different length than indicated by the labels.According to the labels, the nail was supposed to be 36 cm long and in fact it was 40 cm long.The procedure was resumed, without any delay, implanting a s+n back-up nail, in the original hole.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, a review made by the quality engineering team concluded that according to device history records, the two batches were processed on the same days by the same operators in several operations.It is suspected that prior to / during packaging, batch commingling occurred, and the packaging operator may have failed to perform a 100% visual inspection.In addition, review of distribution records does not indicate that both lots were shipped to the complainant's facility.Due to this, corrective actions were initiated, as well as a voluntary market removal.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 historical review concluded that there are no prior actions related to this product and event.According to the drawing print, the device size should be 36 cm.At this time, we do have reason to suspect that the product failed to meet any specifications at the time of manufacture.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: 11.5 X 36 130 D TAN LT LIME
• 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: 17381007
• Report Number: 1020279-2023-01489
• Device Sequence Number: 6302501
• Product Code: HSB
• UDI-Device Identifier: 03596010500922
• UDI-Public: 03596010500922
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71647336
• Device Lot Number: 21KSM0598
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71647340 / LOT: 21KSM0606
• Patient Sex: Unknown