MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 6MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204392
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an achilles tendon repair, when placing the biosure screw in the hole already drilled, the implant fractured in several parts, even remained inside the hole, only a part of the implant but it could be recovered.When placing the implant, it damaged the autograft at the time of placement.The procedure was completed with a surgical delay greater than 30 minutes, and using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor material specification, 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.A clinical evaluation states that the ifu warns that ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Breakage of the screw or loss of fixation may occur the insertion site is not prepared properly.¿ please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Correction: b5: event description.
Event or Problem Description
It was reported that during an achilles tendon repair, when placing the biosure screw in the hole already drilled, the implant fractured in several parts, only a part of the implant remained inside the hole, the other parts could be recovered.When placing the implant, it damaged the autograft at the time of placement.The procedure was completed with a surgical delay greater than 30 minutes, and using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected information in section b5, b7 and h6: health effect - impact code.
Event or Problem Description
It was reported that during an achilles tendon repair, the biosure screw fractured in several parts when placed in the drilled hole; only a part of the implant remained inside the hole while the other parts could be recovered.The insertion site was cleared prior to the anchor placement using a 6 mm femoral drill, 6 mm biosure tap, and 6 mm tunnel.No void was left in the patient.A supersuture was utilized to suture the tendon, and a surgical delay greater than 30 minutes was reported.A back-up device was available.No further complications were reported.

• Brand Name: SCREW BIOSURE REGENESORB 6MM 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.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19851512
• Report Number: 1219602-2024-01616
• Device Sequence Number: 17829249
• Product Code: MAI
• UDI-Device Identifier: 00885554036688
• UDI-Public: 00885554036688
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 72204392
• Device Lot Number: 51121842
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/23/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 80 KG