MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.0MM CANNULATED SCREW 32MM; PLATE, FIXATION, BONE

Model Number	71103232S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the vlp foot procedure, a 1.1 guide was mounted on the motor, an x-ray was taken when the guide was well located, a meter was passed, then a 2.0 cannulated drill was passed through a screw with a washer ring mounted on a screwdriver.At the time of inserting it, when finishing the adjustment, it was evident that the screw head broke, the washer ring fell off, the screw remained inside the patient, it could not be removed.The procedure was completed successfully.The procedure was finished with a smith and nephew back up device.No delay reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested operative report, radiographs or the broken screw, the root cause of the reported breakage cannot be determined.Although we cannot rule out excessive torque as a contributing factor.The retained implantable broken screw was left secure in the bone, therefore, the potential for micro-motion/migration is unlikely.It was reported, the procedure completed with a smith and nephew back up device without delay.There was no indication of any plans to remove the retained screw.Since it was reported the patient was in good health, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to excessive forces applied to implant, poor insertion technique or procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 3.0MM CANNULATED SCREW 32MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11269473
• Report Number: 1020279-2021-00861
• Device Sequence Number: 14233239
• Product Code: HRS
• UDI-Device Identifier: 03596010623959
• UDI-Public: 03596010623959
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71103232S
• Device Catalogue Number: 71103232S
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: Other