MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRIVER CANNULATED 2MM; SCREW, FIXATION, BONE

Model Number	7207193
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while using the cannulated driver, the end (tip) of the screwdriver broke off.All pieces were recovered.The procedure was completed with no delay and a backup device was available.No injury to the procedure was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during surgery, while using the cannulated driver, the end (tip) of the screwdriver broke off inside the patient.All pieces were recovered with the use of fine forceps.The procedure was completed with no delay and a backup device was available.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7207193 driver cannulated 2mm used in treatment, was returned for evaluation.The complaint states: ¿during surgery, while using the cannulated driver, the end (tip) of the screwdriver broke off¿.This a seven year old device.Visual assessment confirms the complaint.Device showed breakage on screwdriver tip.An exact root cause cannot be determined however, excessive force, improper use or cleaning of device may be a factor.The instruction for use states: ¿this product is shipped non-sterile.It must be sterilized before the first use.It must be cleaned and sterilized before every subsequent use¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.Further investigation is not warranted at this time.

• Brand Name: DRIVER CANNULATED 2MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9945702
• Report Number: 1219602-2020-00632
• Device Sequence Number: 3292999
• Product Code: HWC
• UDI-Device Identifier: 03596010253491
• UDI-Public: 03596010253491
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K921481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2020

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: 7207193
• Device Catalogue Number: 7207193
• Device Lot Number: 50484209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 06/30/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/29/2020; 07/02/2020
• 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