MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE SHAFT W/CIR CONNECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 71118231

Device Problems Degraded (1153); Fracture (1260); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

It was reported that during a trauma surgery, it was not possible to identify the marks of the diameter of the drills, so the 9.0mm endcutting irh device was introduced into the canal but as this had a larger diameter than the appropriate one, it got stuck inside the medullary canal.In the attempt to remove it, there was evidence of misalignment and/or damage to the flexible reamer, but the specialist decided to continue the reaming since there was no other equipment and the appropriate reaming had to be performed due to the diameter of the canal.The procedure was resumed, after a significant delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device fractured across the shaft.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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 specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 Description

It was reported that during a trauma surgery, it was not possible to identify the marks of the diameter of the drills, so a drill of a larger diameter (the 9.0mm endcutting irh) was introduced into the medullary canal but it got stuck inside of it.In the attempt to remove it, the flexible shaft w/cir connector got misaligned and/or damaged.The procedure was resumed, after a significant delay, with the same device.Patient was not harmed as consequence of this problem.

• Brand Name: FLEXIBLE SHAFT W/CIR CONNECTOR
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 16886646
• MDR Text Key: 314751931
• Report Number: 1020279-2023-01000
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03596010436528
• UDI-Public: 03596010436528
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K121714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71118231
• Device Catalogue Number: 71118200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: PN: 71118231 / LOT: UNKNOWN.
• Patient Sex: Male