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

Model Number	72203981
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair the distal tip of the healicoil pk inserter came off after anchor insertion.A few millimeters were sticking out of the bone, which help the surgeon to get a good grip with arthroscopic graspers and pulled the tip out.Surgeon reported hard bone-bone prep was done according to surgical technique and anchor insertion seemed as expected.The procedure had a delay shorter than 30 minutes and it was completed with a back up device.No injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
D10, h3, h6: one healicoil pk 4.5mm device used for treatment, was returned for evaluation.Bone condition was reported as hard.Report indicates prep for hard bone was done according to surgical technique, but that was the extent of the detail.No anchor or suture were returned.The return consisted of the inserter only.It had been separated at the weld into two pieces.There was damage at the distal section of the inserter.It appeared that a sharp instrument had been forcefully used causing gouging toward the distal tip.This is where the shaft separated from the insertion tip.There was evidence of weld fracture from force applied.The shaft was slightly flared.The forked inserter tip was dinged and bent.Per instructions for use: ¿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.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Recommended prep instrument for hard bone condition is a 4.5mm awl dilator and a 3.5mmspade drill tip.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9984299
• Report Number: 1219602-2020-00670
• Device Sequence Number: 4442096
• Product Code: MBI
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 07/20/2024
• Device Model Number: 72203981
• Device Catalogue Number: 72203981
• Device Lot Number: 2037199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 03/28/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1