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

Model Number	72203160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that drill bit broke during shoulder repair.Drill bit was looked for over an hour but it could not be found.Patient family was advised and then 3 more hours were spent looking for it with patient open.Device was not found after 6 hours.No injuries to the patient were reported.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned.Without the return of the device in question a root cause for this incident cannot be determined.
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.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.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.) the clinical medical report exceeds the 2000 character limit.Please see mi report for details.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-178875).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-0230867).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: 7245666
• Report Number: 1219602-2018-00196
• Device Sequence Number: 13707453
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: (01)03596010656018(17)220612(10)50663088
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50663088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 05/02/2019
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/26/2018; 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR