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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy procedure, the dilator was inserted into the bone of the humeral head in order to prep for a 5.5mm healicoil regenesorb anchor -as is standard practice.Approximately half way through insertion the inserter plastic handle sheared off from the metal shaft rendering it unable to insert any further.No patient injuries reported.
Additional Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.(b)(4).

• 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: 6940792
• Report Number: 1219602-2017-01287
• Device Sequence Number: 1460337
• Product Code: MAI
• UDI-Device Identifier: 00885554031713
• UDI-Public: (01)00885554031713(17)220131(10)50644602
• Combination Product (Y/N): N
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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: 01/31/2022
• Device Model Number: 72203952
• Device Catalogue Number: 72203952
• Device Lot Number: 50644602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1