MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FIX STPL W/SPKE 10.8X23XSM; STAPLE, FIXATION, BONE

Model Number	71128690
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the fix stpl w/spke 10.8x23xsm was bent upon insertion the patient had a very hard bone, staple could not be used and another staple had to be opened and used.Also a separate hole was made.The procedure was completed, with a delay (less than 30 minutes) , using a s+n back-up device.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
G3, h2,h3 and 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, the fix stpl w/spke 10.8x23xsm was bent upon insertion and a back-up was used, creating a separate bone hole.It was reported the patient had very hard bone.The root cause of the reported event could not be definitively concluded; however, a user-related technique may have been a contributing factor.According to the report, the procedure was completed with a delay of less than 30 minutes.No patient injury or other complications were 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.Possible probable cause could include but not limited to surgical technique or user error.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.We consider this investigation closed.

• Brand Name: FIX STPL W/SPKE 10.8X23XSM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11858093
• Report Number: 1020279-2021-04515
• Device Sequence Number: 4016679
• Product Code: JDR
• UDI-Device Identifier: 00885556014752
• UDI-Public: 00885556014752
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71128690
• Device Catalogue Number: 71128690
• Device Lot Number: 20ET38006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention