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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery, the screw was loose and could not be fixated when it was inserted into the bone hole.No patient injuries or delay reported.Although no backup device is reported, there is no information that reasonably suggests a procedure cancellation, change in surgical technique nor use of competitor device occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the reported 72204389 5x20 biosure regenesorb screw, used in treatment, has been returned for evaluation.From the information provided, the screw would not fixate in the tunnel.Used screw was returned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site with the proper prep device.Improper tunnel size.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
H10: the reported 5x20 biosure regenesorb screw, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw would not fixate in the tunnel.An exact root cause cannot be determined with confidence.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIOSURE REGEN SCREW 5 X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10003826
• Report Number: 1219602-2020-00696
• Device Sequence Number: 2804472
• Product Code: MAI
• UDI-Device Identifier: 00885554036572
• UDI-Public: 00885554036572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/01/2020

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: 09/18/2021
• Device Model Number: 72204389
• Device Catalogue Number: 72204389
• Device Lot Number: 50759570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 06/30/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/01/2020; 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR