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

Model Number	72203982
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healicoil pulled out at insertion (soft bone).No patient injury was reported.
Additional Manufacturer Narrative
Device has not been returned for evaluation.The clinical details were reviewed, and it was identified that the patient had soft bone.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7547396
• Report Number: 1219602-2018-00659
• Device Sequence Number: 1697980
• Product Code: MBI
• UDI-Device Identifier: 00885554032130
• UDI-Public: (01)00885554032130(17)221221(10)50703862
• Combination Product (Y/N): N
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 12/21/2022
• Device Model Number: 72203982
• Device Catalogue Number: 72203982
• Device Lot Number: 50703862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/28/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1