MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TI ANCHOR 2.7MM 2-0 SUTURE GRAVITY SUTURE ANCHOR; SCREW, FIXATION, BONE

Model Number	86TA2027
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the tip of the wright medical titanium gravity screwdriver broke off in the screw once implanted.This happened twice in the same case with two different anchors.With the first anchor, it was right as the screw portion of the device was advanced to be flush with the bone.There was a snap and it was noted that the screw driver was broken off in the cannulated portion of the screw.For the second anchor, it was advanced flush with the bone, however the surgeon wanted to give it an additional turn to fully seat it.When she re-inserted the screw driver to advance the screw further, the driver again broke off in the cannulated portion of the screw.
Additional Manufacturer Narrative
The reported event could be confirmed since images of the device were provided showing the tip of the driver broken off.Feedback received from r&d confirmed pilot holes are not necessary with the use of a ti anchor.Regarding the second screw insertion/tip breakage, it was noted that if the surgical team removed the driver then re-engaged it, there is a chance they did not fully seat the driver in the screw and caused the driver to chip or break in that way.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The current instructions for use states that: "inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs.Leaving the fragment in the patient." no indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the tip of the wright medical titanium gravity screwdriver broke off in the screw once implanted.This happened twice in the same case with two different anchors.With the first anchor, it was right as the screw portion of the device was advanced to be flush with the bone.There was a snap and it was noted that the screw driver was broken off in the cannulated portion of the screw.For the second anchor, it was advanced flush with the bone, however the surgeon wanted to give it an additional turn to fully seat it.When she re-inserted the screw driver to advance the screw further, the driver again broke off in the cannulated portion of the screw.

• Brand Name: TI ANCHOR 2.7MM 2-0 SUTURE GRAVITY SUTURE ANCHOR
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13943696
• Report Number: 3010667733-2022-00139
• Device Sequence Number: 6468188
• Product Code: HWC
• UDI-Device Identifier: 00840420165947
• UDI-Public: 00840420165947
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 07/25/2026
• Device Model Number: 86TA2027
• Device Catalogue Number: 86TA2027
• Device Lot Number: 1706469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female