MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN BIOABSORBABLE BIORCI AND GTS INTERFERENCE SCREW; SCREW, FIXATION, BONE

Model Number	7207679
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acl, tibia screw fixation procedure, the biosure screw broke off when the surgeon was inserting the screw into the tibial tunnel.The broken pieces were retrieved from the patient with biosure driver.The procedure was completed with non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.This case reports the breakage of a bioabsorbable biorci and gts interference screw, per case the broken pieces were all retrieved from the patient.It was communicated via e-mail that there have been 3 events within the last few months with the same surgeon.It was also noted via e-mail that the patient was good after the operation, and that the surgeon was satisfied.Since no patient harm has been reported no further clinical investigation is warranted.Insufficient product identification information was provided and thus a complaint history review could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product information was provided and thus an instructions for use review, risk management review could not be conducted.Insufficient product identification information was provided, and thus, a print specifications review could not be conducted.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN BIOABSORBABLE BIORCI AND GTS INTERFERENCE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 14750763
• Report Number: 1219602-2022-00896
• Device Sequence Number: 6047201
• Product Code: HWC
• UDI-Device Identifier: 03596010459978
• UDI-Public: 03596010459978
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Model Number: 7207679
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown