MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STITCHER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71935021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a procedure, the tip of the bone fragment stitcher was broken.It is unknown if there was a backup device available, a delay in the procedure or further complications.
Additional Manufacturer Narrative
Report was inadvertently submitted under manufacturer number (b)(4) but the correct manufacturer number is (b)(4).
Event or Problem Description
It was reported that, during a procedure, the tip of the bone fragment stitcher was broken.The broken piece was removed from the patient's wound, and there was no injury to patient it is unknown if there was a backup device available and if there was a surgical delay.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection confirmed the tip is broken off the device.The device shows significant signs of wear.This case reports the tip of the bone fragment stitcher broke of inside the patient.Per email communication, the broken piece was recovered and there was no harm to the patient.It is unknown whether there was a delay, or if a backup device was used.No patient injury or other complications were reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, wear from prolonged use, misuse or rough handling, or inadequate routine maintenance.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.H11: d3 & g1 corrected: manufacturing name and address.This report was inadvertently submitted under manufacturer report number ¿1020279¿, correct manufacturer report number is ¿1219602.¿.

• Brand Name: STITCHER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10463895
• Report Number: 1020279-2020-04269
• Device Sequence Number: 2553222
• Product Code: LXH
• UDI-Device Identifier: 00885556466940
• UDI-Public: 00885556466940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71935021
• Device Catalogue Number: 71935021
• Device Lot Number: 16HCT0003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020; 08/02/2022
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 12/07/2021; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown