MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 30MM; SCREW, FIXATION, BONE

Model Number 72201782

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2018

Event Type  malfunction  

Event Description

It was reported that the graft diameter was measured at 9mm, thus the surgeon up biosure screw to 10mm.However, after tapping the tibia bone using the screw starter, he found that the screw was too big.He asked to use the 9mm screw, and even after tapping, the screw broke half way through anchoring the screw into patient¿s bone.Part of the tip of the 9mm screw was left inside.Since there was no biosure tap instruments available, surgeon had to use other fixation technique to anchor the tibia component.Thus, he used our staple instead to do a fixation at the tibia.Part of the tip of the 9mm screw was left inside.Since there was no biosure tap instruments available, surgeon had to use other fixation technique to anchor the tibia component.Thus, he used our staple instead to do a fixation at the tibia.

Manufacturer Narrative

One sterile 72201782 9x30mm biorci-ha screw returned.Inspection verified that this is a 9mm product.The head does not show signs of stripping.The portion returned confirms fracture of the distal tip with distal threads missing.A 10mm portion was not returned.The anchor is chewed up which is a symptom related to entanglement with a guide wire.The remaining threads are rolled, compressed and fractured which indicate over torque during and after rotation ceased.The symptoms are consistent with an inadequate tunnel or hard bone was encountered.Interference screws recommend 1:1 screw size to tunnel size for best surface interference contact.Use an appropriate size tap to pre-tap the insertion site prior to screw insertion.In cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.No root cause related to the manufacturing of this device was confirmed.No further investigation is warranted.Updated.

• Brand Name: BIOSURE HA 9MM X 30MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7594010
• MDR Text Key: 111318592
• Report Number: 1219602-2018-00728
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611789
• UDI-Public: (01)03596010611789(17)221031(10)50694020
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 72201782
• Device Catalogue Number: 72201782
• Device Lot Number: 50694020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2008
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1