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

Catalog Number	72203708
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 72203708 healicoil regenesorb 5.5mm suture anchor with ultra tape and ultrabraid returned.The complaint indicated ¿it was reported that when the package was opened the anchor was discovered to be broken¿.The fragments were not returned.The returned device is a used product.It has surgical remains attached to device, anchor and ultratape, ultrabraid.Since the allegation was said to have occurred prior to procedure, there are no clinical details included.Detailed evaluation is limited without these.Based upon the condition of the anchor, over torque is a factor.The spiral is fractured in a location aligned with a shaft graduation to a larger diameter.This occurs with resistance from the insertion hole.Please note: ifu reads: ¿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.¿ no root cause associated with the manufacture of this device could be supported nor proven.No further investigation warranted.(b)(4).
Event or Problem Description
It was reported that when the package was opened the anchor was discovered to be broken.A backup device was available to complete the procedure without patient impact.Additional information received as the result of the investigation indicates that the device broke during insertion.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6938709
• Report Number: 1219602-2017-01285
• Device Sequence Number: 1141725
• Product Code: MAI
• UDI-Device Identifier: 00885554031423
• UDI-Public: (01)00885554031423(17)190330(10)50594020
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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: 03/30/2019
• Device Catalogue Number: 72203708
• Device Lot Number: 50594020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1