MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203708
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device screw thread broke, causing the threads to be ripped off.The claimant alleged that the broken screw remain inside the patient and that is not possible it's removal.A backup was used to complete the procedure.
Additional Manufacturer Narrative
One 5.5mm healicoil rsb sa anchor system inserter was returned for evaluation.No anchor or sutures were returned for examination.Visual assessment of the inserter showed one of the inserter tines is bent.This condition of the inserter indicates the device was subjected to excessive force.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7663668
• Report Number: 1219602-2018-00866
• Device Sequence Number: 645864
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: (01)00885554031423(17)210403(10)50724825
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: 04/03/2021
• Device Catalogue Number: 72203708
• Device Lot Number: 50724825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1