MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR; SAW, POWERED, AND ACCESSORIES

Model Number	72201395
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during ask shoulder, the tip of the spade drill bit for 2.9 anchor broke off in the glenoid.It broke off in such a way that it sank into the bone and was no longer visible.Procedure was resumed, after a non-significant delay (less or equal to 30min), with a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Our clinical investigation concluded: based on the information provided, the tip of the drill bit broke off in such a way that it sank into the bone and was no longer visible.The tip is comprised of 17-4 (ph) ss and it most used in surgical instruments and not intended for long-term implantation.However, since the tip is embedded in the bone, micro-motion and or migration of the retained tip is unlikely.It was reported, the procedure was completed, after a non-significant delay, with a back-up device.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that, during an ask shoulder, the tip of the spade drill bit broke off in the glenoid.It broke off in such a way that it sank into the bone and was no longer visible.Procedure was resumed, after a non-significant surgical delay, using a back-up device.No other complications were reported.

• Brand Name: SPADE DRILL BIT FOR 2.9 ANCHOR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12647806
• Report Number: 1219602-2021-02293
• Device Sequence Number: 14577481
• Product Code: HAB
• UDI-Device Identifier: 03596010595546
• UDI-Public: 03596010595546
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72201395
• Device Catalogue Number: 72201395
• Device Lot Number: 50226632
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown