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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a bankart (labrum) repair, the doctor drilled a first bone hole at 5 o'clock and put the 1st anchor in with no complications.Then, when drilling the second bone hole at 4 o'clock on the glenoid with the 1.7mm twist drill (s), they realized it was difficult to bottoming out the drill.Therefore, they took the drill out of the guide and realized that the drill they were using was actually an xl length drill bit.The procedure was successfully completed without delay using the correct drill bit from the same box.No patient injuries or other 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
H3, h6: one twist dril for 1.7mm suture anchor 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 situation.
Additional Manufacturer Narrative
H10: one 72203855 twist drill for 1.7mm suture anchors used for treatment but was 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 with regards to product overall length verification.The allegation was confirmed.Complaint history review indicated similar allegations for the lot number reported.Initial batch review did not indicate a condition, product or procedure failure that supported the allegation but the condition was subsequently verified.

• 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: 9745620
• Report Number: 1219602-2020-00385
• Device Sequence Number: 618770
• Product Code: MBI
• UDI-Device Identifier: 00885554030112
• UDI-Public: 00885554030112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 04/02/2020; 02/24/2022
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/19/2020; 04/06/2020; 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: Male