MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MANSFIELD TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203160
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was drilling, the chuck occasionally came off and the tip of drill broke, remaining in the patient.The surgeon decided to leave the piece in the patient.Broken piece moved from its original position, therefore surgeon performed a revision surgery on (b)(6) 2018 to remove the remaining drill tip and prevent any other complication on the patient.Patient current condition is good.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on all information requests.Proceed based on information provided/available for the investigation; if no further clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's is current condition is reported as good.Therefore no further clinical assessment is warranted based on the information provided.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC. MANSFIELD; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7775818
• Report Number: 1219602-2018-01035
• Device Sequence Number: 13782877
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: (01)03596010656018(17)221214(10)50702708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2018

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 Expiration Date: 12/14/2022
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50702708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/12/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 49