MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FIX STPL W/SPKE 12X23 SML; STAPLE, FIXATION, BONE

Model Number 71128692

Device Problems Connection Problem (2900); Material Deformation (2976)

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

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: case (b)(4).

Event Description

It was reported that during surgery, fixation staple w/spike 12mmx23mm small was loaded appropriately onto staple driver, and while it was being inserted, the staple splayed to the sides and did not enter the bone appropriately.The surgeon removed it, and on inspection, it was noticed that the end of the staple had widened.Surgeon was able to bend and manipulate staple back into shape with minimal effort.A backup device from smith and nephew was used instead to complete the procedure.A delay of less than 30 minutes was reported.There was no injury to patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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, per the complaint details, the device malfunctioned during use (the staple splayed after inserted with a mallet).It was communicated, however, that all material was retrieved from the joint and the case successfully concluded with a s+n back-up device without further complications.Per the anz product complaint form, there was no adverse outcome for the patient and no further information is available.The root cause of the reported event could not be definitively concluded.Patient impact beyond the reported 0-30-minute surgical delay would not be anticipated, as no patient injury was reported.No further medical assessment could be rendered at this time.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 a fit issue, excessive force applied to implant or poor insertion 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.

• Brand Name: FIX STPL W/SPKE 12X23 SML
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479709
• MDR Text Key: 239664031
• Report Number: 1020279-2021-02150
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010544537
• UDI-Public: 03596010544537
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71128692
• Device Catalogue Number: 71128692
• Device Lot Number: 20FT38347
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention