MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE REGEN SCREW 5 X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204389
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an arthroscopy the screw broke, the surgeon prepared the hole well with a 5mm drill bit and was very delicate during the insertion.The procedure was completed with a backup device and no delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during an arthroscopy the screw broke, the surgeon prepared the hole well with a 5mm drill bit and was very delicate during the insertion.Broken pieces were removed with tweezers.The procedure was completed with a backup device and no delay or further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the customer provided image confirms that the device is broken.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: read these instructions completely prior to use.Incomplete screw insertion may result in poor screw performance.Breakage of the screw or loss of fixation may occur if the insertion site is not prepared properly.Inspect to confirm that the interference screw is fully seated onto the driver prior to insertion.If the interference screw is not properly seated on the driver, damage to or breakage of the screw may result.Failure to fully seat the screw may result in breakage of the screw.Use of a driver other than the appropriate biosure driver may result in breakage of the screw.5 mm biosure regenesorb interference screws are to be used with the 5 mm biosure driver.All other biosure regenesorb interference screws are to be used with the standard biosure driver.The biosure tap is recommended for use with bone-tendon-bone grafts prior to inserting the interference screw.Use the appropriate-size tap over the 1.2 mm guide wire to prepare the insertion site.In cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.The reverse threaded biosure regenesorb interference screws are not intended to be used in bone-tendon-bone indications.The complaint was confirmed.Factors that could have contributed to the reported event include an application of inappropriate or excessive force.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.

• Brand Name: BIOSURE REGEN SCREW 5 X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10938166
• Report Number: 1219602-2020-01975
• Device Sequence Number: 2419056
• Product Code: MAI
• UDI-Device Identifier: 00885554036572
• UDI-Public: 00885554036572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: 72204389
• Device Catalogue Number: 72204389
• Device Lot Number: 50813015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 01/08/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/09/2020; 01/17/2021
• 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: Required Intervention
• Patient Age: 15 YR