MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported that, during a shoulder surgery, when the surgeon was implanting the "twinfix suture anchor (pk 4.5mm)" into the patient shoulder, a piece of the handle near the screw broke inside the patient when it was being screwed-in.The surgeon was unable to retrieve the metal piece as it is attached to the anchor.Therefore, the metal piece remained inside the patient's anatomy.Although the procedure was completed with the same device, the surgeon stated "most of the anchor is inside the bone, but a little piece of the metal is sticking out".It is unknown if there was a surgical delay and no further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a shoulder surgery, when the surgeon was implanting the "twinfix suture anchor (pk 4.5mm)" into the patient shoulder, a piece of the handle near the screw broke inside the patient when it was being screwed-in.The surgeon was unable to retrieve the metal piece as it is attached to the anchor.Therefore, the metal piece remained inside the patient's anatomy.Although the procedure was completed without significant delay using the same device; the surgeon stated "most of the anchor was inside the bone, but a little piece of the metal was sticking out".No additional complications were reported.

Manufacturer Narrative

H10: h3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat event.A review of risk management files found that the reported failure was documented appropriately.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of this complaint case revealed the broken inserter was left in the implanted anchor.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.Therefore, no further medical assessment is warranted.There is no indication that the material did not meet these requirements prior to release to distribution.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10612377
• MDR Text Key: 209340234
• Report Number: 1219602-2020-01495
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 50671887
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention