MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE; PROSTHESIS, RIB REPLACEMENT

Catalog Number	72203981
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon insertion the anchor shredded it's thread.After which the surgeon determined that the bone quality was very hard and possibly the issue cause.They used a threaded tap for the second anchor and had no issues.The biggest concern was the fragments of peek left behind on this anchor, which the surgeon cleaned up.No patient injury or significant delay were reported.No additional bone hole was necessary.
Additional Manufacturer Narrative
One 72203981 healicoil pk 4.5mm suture anchor used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be visually evaluated.If objective evidence, relevant information, packaging or product becomes available, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1.Damaged or use of other than recommended prep instrument size or types.2.Pressure or excess torque applied.3.Inadequate bone quality resulting in anchor pullout or loss of fixation.4.Unexpected bone condition/density.5.Breakage and damage can occur due to use of sharp instruments to manage or control the suture.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.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Recommended prep instrument for the 4.5mm anchor used on normal bone condition is a 3.8mm tapered awl.Product met specifications upon release to distribution.Complaint history review found no other report for this lot.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• Common Device Name: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8690869
• Report Number: 1219602-2019-00683
• Device Sequence Number: 11374161
• Product Code: MDI
• UDI-Device Identifier: 00885554032123
• UDI-Public: 00885554032123
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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 Catalogue Number: 72203981
• Device Lot Number: 2021404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1