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 Code Available (3191)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ultratape was pierced through itself when the healicoil was deployed and disengaged from inserter.This happened in back to back anchors in the same case.This patient had to have one extra bone hole made because of the failed anchor.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• 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: 6906845
• Report Number: 1219602-2017-01227
• Device Sequence Number: 16307332
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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 Model Number: 72203981
• Device Catalogue Number: 72203981
• Device Lot Number: 50665343
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1