MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG DILATOR 5.5MM DISPOSABLE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203952
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft of dilator broke and rotates freely within the handle.Improvement of handle strength was requested.The device broke outside the patient and there was no issue with the anchor.No patient injury was reported.Back up was not available.
Additional Manufacturer Narrative
One 5.5 healicoil rg dilator was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The shaft has come free from the handle.Dimensional assessment of the shafts knurl confirmed it met print specifications.As reported the patient had hard bone and the insertion site was prepared with a 3.8mm tapered awl and this dilator.Per the healicoil rg ifu "when a larger hole is required, as in the case with hard bone, use a drill to create a pilot hole for the anchor, then insert the threaded dilator to better prepare the bone for the anchor".Per the dilator ifu under precautions "as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure".

• Brand Name: HEALICOIL RG DILATOR 5.5MM DISPOSABLE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7821089
• Report Number: 1219602-2018-01144
• Device Sequence Number: 1052900
• Product Code: MAI
• UDI-Device Identifier: 00885554031713
• UDI-Public: (01)00885554031713(17)200512(10)50549467
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 05/12/2020
• Device Model Number: 72203952
• Device Catalogue Number: 72203952
• Device Lot Number: 50549467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR