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

Model Number	72203709
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a rotator cuff repair, the healicoil suture anchor's tip broke on the bone surface.All of the pieces were removed from the patient.It is unknown if another bone hole was required.The procedure was completed without delay using a back-up device.No patient injury 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: the reported 4.75mm reusable healicoil rg dilator, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the tip broke off during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H3, h6: the reported 4.75 healicoil rg disposable dilator, used in treatment, has been returned for evaluation.Device lot is over six years old.Visual assessment of the device confirmed the reported complaint.The distal tip has broken off and was not returned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: HEALICOIL RG DILATOR 4.75MM REUSABLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9564817
• Report Number: 1219602-2020-00049
• Device Sequence Number: 2224617
• Product Code: LXH
• UDI-Device Identifier: 00885554030501
• UDI-Public: 00885554030501
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2020

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: 72203709
• Device Catalogue Number: 72203709
• Device Lot Number: 50467744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/18/2020; 05/21/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/19/2020; 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1