MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FOR 1.7MM ALL STR ANCHRS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203855
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a sub-pec tenodesis, when drilling it was noticed that the length of the twist drill bit was longer than it usually is.When hitting the far cortex, and the drill looked to be abnormally long, the surgeon stopped drilling any farther.Another drill bit was opened up and the difference was noticeable.The drill hole was used to implant the anchor with no issues.Surgery was not delayed.The patient was not injured.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one twist drill for 1.7mm suture anchors was used for treatment but was not returned for evaluation.Per instruction for use: ¿prior to use, inspect the device to ensure it is not damaged.Instructions for use contains precautionary statements and recommendations for proper use of product.This product is under review.The allegation was confirmed.Complaint history review indicated similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation but the condition was verified.Additional investigation by engineering resulted with initiation of a corrective action as a response to the mixed product situation.

• Brand Name: TWIST DRILL FOR 1.7MM ALL STR ANCHRS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9720504
• Report Number: 1219602-2020-00230
• Device Sequence Number: 13541860
• Product Code: MBI
• UDI-Device Identifier: 00885554030112
• UDI-Public: 00885554030112
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2022

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: 08/24/2024
• Device Model Number: 72203855
• Device Catalogue Number: 72203855
• Device Lot Number: 2039311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 02/24/2022
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/18/2020; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown