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

Catalog Number	72203160
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient to remove a broken drill tip that was left during a bankart repair procedure performed in (b)(6) 2018.A mini c arm was used to localize the retained foreign body.Once identified, it was removed with a grasper.No further complications were reported.Patient was reported to be doing well.
Additional Manufacturer Narrative
Two flexible curved twist drills for 2.3 sa were returned for evaluation.Visual assessment of sample (a) showed the distal end (flex cable link is slightly bent which is unremarkable for a device that has been used.Visual assessment of sample (b) confirmed the reported complaint of breakage.The drill has fractured at the distal weld zone of the flex cable link to the drill head.Material has broken off from the weldment area of the drill head and was not returned.Examination of the weld bead characteristics confirmed adequate penetration between the welded components.The flex cable link is also bent at the drill shaft.The distal end of the flex cable link is also slightly unwound, which is a condition seen when the drill is run in reverse.Dimensional analysis: dimensional assessment of the drill component confirmed they are within print specifications.Material analysis: all component materials were analyzed and were found to meet print specifications.The observed breakage indicates the drill was subjected to excessive torsional forces during use.This investigation could not identify any evidence of product contribution to the reported complaint.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.Master c-(b)(4) (previously closed) added complaint d/t notification of revision, then rec'd explanted product.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided by the legal team.If no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), 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.) in conclusion: based on the product evaluation findings the root cause of the drill tip breakage and resultant retained foreign body was likely excessive torsional force and possible reversal of the drill upon removal, which are both noted in the ifu precautions(c-(b)(4)).The foreign body which was retained approximately 1 month is not approved for implantation and was the root cause for the revision and was resolved via a successful retrieval of the retained drill tip (c-(b)(4)).The patient impact beyond the extensive surgical delay, reported subsequent complications and the retrieval procedure cannot be concluded.The reported subsequent complications; however, are a result of the extended surgical delay and do not reflect a causal relationship to the performance of the device.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8323581
• Report Number: 1219602-2019-00166
• Device Sequence Number: 1692366
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: 03596010656018
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 06/12/2022
• Device Catalogue Number: 72203160
• Device Lot Number: 50663088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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
• Patient Age: 16 YR
• Patient Weight: 66