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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zip code: (b)(6).
Event or Problem Description
It was reported that the bone was not particularly hard.Surgeon inserted anchor making couple of turns at which point he realised the threads had crumbled and the anchor was broken.Surgeon removed the anchor and inserted a different anchor.No patient injury was reported.
Additional Manufacturer Narrative
One (b)(4) healicoil pk 5.5mm with ultra tape product returned.The complaint stated: "it was reported that the bone was not particularly hard.Surgeon inserted anchor making couple of turns at which point he realized the threads had crumbled and the anchor was broken." inserter, ultrabraid, ultratape and partial anchor were returned.The anchor threads are broken.The small pieces were not returned.The distal threads remaining are burnished and quite flattened.This is consistent with excess torque applied.The prep reported was applicable for average bone density.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It is the responsibility of the surgeon to determine the patient's bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.There are no other complaints for this lot.No root cause associated with the manufacture of this device was confirmed.
Additional Manufacturer Narrative
A photo of a procedure inventory sheet was provided.This confirmed a combination of smith & nephew and stryker products were used for this case.Due to no product return and lack of prep details the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• 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: 7550018
• Report Number: 1219602-2018-00669
• Device Sequence Number: 144071
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: (01)00885554032109(17)210711(10)50610516
• 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,Followup
• Report Date (Section B): 11/08/2018

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: 50610516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 11/07/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/21/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1