MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 HS SUTR ANCHR W/2 28" DUR; STAPLE, FIXATION, BONE

Catalog Number	72200796
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a procedure when the package was opened, the tip of anchor was found to be already out of the sterile packaging.There was no delay or patient injuries but it is unknown how the procedure was finished since no backup device was available to complete it.Attempts were made to retrieve further details about the event but the complainant does not have more information.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One twinfix ti hs suture anchor device was not used for treatment but was returned for evaluation.The complaint stated: ¿the tip of anchor was found to be already out of the sterile packaging.¿ the tyvek pouch was returned still sealed.The product was not protruding from the tyvek pouch at that time, but there was a pierce where it had poked through at some point during transit.The tip protective tube, as well as the poly bag were out of location and found free floating inside the tyvek pouch.The condition was recently brought to engineering¿s awareness in order to revise the packaging for creating a more appropriate fit and removing the pouch slack for the shorter device code.The device history records and the complaint history, for this lot, were reviewed and it is concluded that the product met specifications at the time of release to distribution.

• Brand Name: TWINFIX TI 2.8 HS SUTR ANCHR W/2 28" DUR
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9249581
• Report Number: 1219602-2019-01334
• Device Sequence Number: 2031066
• Product Code: JDR
• UDI-Device Identifier: 03596010584489
• UDI-Public: 03596010584489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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 Expiration Date: 10/11/2023
• Device Catalogue Number: 72200796
• Device Lot Number: 50763859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1