MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203983
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that two healicoil anchors broke while being advanced into bone tunnel.Rep arrived shortly thereafter.Hard bone as per surgeon, asked for bone tap, advised none available in hospital except for 3.8 gold awl.Offered healicoil regenesorb anchors, as awl/dilator available on hand.Surgeon declined, asked for two more healicoil pk anchors.Observed, anchor placement done as per surgical technique.The 3rd & 4th anchors implanted successfully.Surgery completed without any other incident.Slight delay to surgery.
Additional Manufacturer Narrative
One 5.5 mm pk sa healicoil anchor was returned for evaluation.Visual assessment of the device confirmed its breakage.The distal threads of the anchor have broken off.The material surface of the anchor is heavily burnished.As reported the patient had hard bone and the insertion site was prepared using a 3.8 awl.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7474641
• Report Number: 1219602-2018-00514
• Device Sequence Number: 1314122
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: (01)00885554032109(17)210711(10)50610513
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 07/11/2021
• Device Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: 50610513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR