MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 5MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204390
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during mcl surgery, while inserting the screw in the tunnel, the screw broke.Non-significant delay was reported.The procedure was completed with a s+n back-up device.Non-significant delay was reported, and no patient complications were reported.
Event or Problem Description
It was reported that during mcl surgery, while inserting the screw in the tunnel, the screw broke.All the broken pieces were removed.The procedure was completed with a s+n back-up device.The same hole was made big and bigger screw of 6*25 was used in it.This resulted in a non-significant surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in b5 and h6 (health effect - impact code).Correction in d3: manufacturing name, city and address.This report was inadvertently submitted under manufacturer number ¿1643264¿, the correct manufacturer number is ¿1219602.¿.
Additional Manufacturer Narrative
H10: h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to 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 review of the polymer found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.Per case details, all the broken pieces of the screw were retrieved from the patient.The procedure was completed using a s+n back-up device with a non-significant delay.No patient complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SCREW BIOSURE REGENESORB 5MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14087899
• Report Number: 1643264-2022-00125
• Device Sequence Number: 5289424
• Product Code: MAI
• UDI-Device Identifier: 00885554036664
• UDI-Public: 00885554036664
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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 Expiration Date: 07/25/2022
• Device Model Number: 72204390
• Device Catalogue Number: 72204390
• Device Lot Number: 50818759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 05/07/2022; 06/27/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/11/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male