MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE TUNNEL PLUG LARGE 10-11MM; ACCESSORIES,ARTHROSCOPIC

Model Number	013562
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy procedure the bone tunnel plugs were being taken out of the acl sets and both, the small (b)(4) and large (b)(4) broke into two parts as they were being taken out of the set.The procedure was completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 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 a relationship found between the device and the reported event.A complaint history review found similar reported events.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A review of the customer provided image finds the devices from this complaint and the -1 complaint.Both are fractured.The complaint was confirmed, and the root cause was associated with unintended use of the device.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.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.Internal complaint reference case-2022-00116618-2 a1: space updated to blank since there was a patient involved but no specific information about the patient.

• Brand Name: BONE TUNNEL PLUG LARGE 10-11MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 15299154
• Report Number: 1219602-2022-01239
• Device Sequence Number: 2407203
• Product Code: NBH
• UDI-Device Identifier: 03596010091147
• UDI-Public: 03596010091147
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Model Number: 013562
• Device Catalogue Number: 013562
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown