MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG DILATOR 4.75MM REUSABLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72203709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a right shoulder arthroscopy and rotator cuff procedure, the tip of awl was tapped in with mallet then turned in with surgeons hands as the threads engaged the bone.Some tissue got stuck as he was trying to turn the awl into bone so he removed awl and then shaved some tissue away.When he put awl back in to properly dilate the hole, it was noticed that the little tip was missing and presumably broke off inside the patient head of humerus while tapping greater tuberosity.Then a 4.5 pk awl was used to tap in and then again did the 4.75mm awl with tip missing just to ensure we got the hole properly dilated.The pieces were not retrieved from the patient.The procedure was successfully completed without delay using a back-up device in the same bone hole.No 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
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the complaint revealed that the root cause for the reported complaint could not be determined.Based on the limited information provided, the extent of patient impact cannot be determined based on the details provided.Therefore, no further medical assessment is warranted.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of the complaint revealed that the root cause for the reported complaint could not be determined.Based on the limited information provided, the extent of patient impact cannot be determined based on the details provided.Therefore, no further medical assessment is warranted.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A visual inspection reveals the device appears to be worn from use.The inspection confirms the distal tip of the threads has been fractured from the device and was not returned with the device.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.

• Brand Name: HEALICOIL RG DILATOR 4.75MM REUSABLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10975150
• Report Number: 1219602-2020-02012
• Device Sequence Number: 4214527
• Product Code: LXH
• UDI-Device Identifier: 00885554030501
• UDI-Public: 00885554030501
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2021

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: 72203709
• Device Catalogue Number: 72203709
• Device Lot Number: 50509575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 04/09/2021; 08/31/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 04/12/2021; 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR