MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 25MM; SCREW, FIXATION, BONE

Model Number 72201781

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 07/01/2020

Event Type  Injury  

Event Description

It was reported that during a cl reconstruction surgery, when screw-in, the screw broke off.Screw was successfully removed from the patient.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One biosure ha 9x25mm screw used in treatment, was returned for evaluation.The screw head was in good condition.A small segment of the most distal thread was chewed up, torn off, and missing.The symptom is aligned with entanglement with a guide or other instrument and excess pressure applied from or continued driver rotation after product rotation ceased.Force was a factor.The condition is consistent with unexpected bone density encountered or an inadequate tunnel diameter.Product having a tapered shape requires tunnel diameter accommodate the largest thread diameter.Interference screws recommend 1:1 screw size to tunnel size for best surface interference contact per instructions for use: ¿use an appropriate size tap to pre-tap the insertion site prior to screw insertion.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely, prior to use.In cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.¿ complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.No root cause related to manufacturing of the implant was confirmed.Product met specifications upon release to distribution.

• Brand Name: BIOSURE HA 9MM X 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10397313
• MDR Text Key: 202582188
• Report Number: 1219602-2020-01237
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611772
• UDI-Public: 03596010611772
• Combination Product (y/n): N
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201781
• Device Catalogue Number: 72201781
• Device Lot Number: 50807322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR