MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203981
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the suture was trapped and would not slide.No other information is available.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7051307
• Report Number: 1219602-2017-01455
• Device Sequence Number: 13989484
• Product Code: MBI
• UDI-Device Identifier: 00885554032123
• UDI-Public: (01)00885554032123(17)220519(10)50665343
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: 05/19/2022
• Device Model Number: 72203981
• Device Catalogue Number: 72203981
• Device Lot Number: 50665343
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1