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

Model Number 71118200

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported that flexible shaft w/cir connector broke inside the patient because of too much tension during reaming.No patient injuries were reported.Unknown the type of procedure being performed.No surgical delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms that the flexible reamer shaft fractured within the shaft via mechanical overload.If sufficient offset bending or torsional forces are applied to the reamer shaft during use that exceeds the strength of the material, a mechanical overload fracture can occur.The device was manufactured in 2015.This device shows significant signs of wear / usage.A medical investigation was conducted and based on the information provided and the results of the product evaluation the root cause of the reported breakage is likely due to a user vs procedural event.Per the product evaluation ¿if sufficient offset bending or torsional forces are applied to the reamer shaft during use that exceeds the strength of the material, a mechanical overload fracture can occur.¿ the material of the flexible shaft is 17-4 ph stainless steel per m000128 which is manufactured and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible corrosion, local irritation / discomfort, and / or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear / tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• 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
• MDR Report Key: 10638050
• MDR Text Key: 210084693
• Report Number: 1020279-2020-05179
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03596010436528
• UDI-Public: 03596010436528
• Combination Product (y/n): N
• PMA/PMN Number: K121714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71118200
• Device Catalogue Number: 71118200
• Device Lot Number: 15FM19001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention