MAUDE Adverse Event Report: LO-PRO SCRW,3.5X 54MM; PLATE, FIXATION, BONE

Model Number	LO-PRO SCRW,3.5X 54MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 09/10/2021, it was reported by a sales representative via phone that an ar-8935-54 drill guide locking 3.5 screw, head broke off during insertion.All fragments were removed.This was discovered during use in an ankle arthroscopy on (b)(6) 2021. the case was completed by using an ar-8935-56 screw into the same insertion site.Additional information 9/13/2021 on 09/13/2021, it was reported by a sales representative via email that an ar-8935-54 drill guide locking 3.5 screw head, broke off during insertion.The surgeon cut the ar-8925t k-less tightrope, and remove the broken screw and ar-9943c-04 plate.This was discovered during use in an ankle arthroscopy on (b)(6) 2021. the case was completed by using a new ar-8925t k-less tightrope with driver, into the same insertion site using the same ar-99343c-04 plate.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8935-54 was received for investigation.Visual inspection identified that the screw head was returned broken off from the body of the screw.Using digital caliper id: 011, it was determined that approximately 2.0490" of the screw body remained intact.Severe thread damage was noted, and the breakage site at the proximal end was noticeably warped.Using digital micrometer id: 224, it was revealed that the screw head met width dimension specifications.The cause remains undetermined.A probable cause is attributed to user-applied mechanical forces during screw insertion.

• Brand Name: LO-PRO SCRW,3.5X 54MM
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12540226
• Report Number: 1220246-2021-03706
• Device Sequence Number: 3373421
• Product Code: HRS
• UDI-Device Identifier: 00888867050761
• UDI-Public: 00888867050761
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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 Model Number: LO-PRO SCRW,3.5X 54MM
• Device Catalogue Number: AR-8935-54
• Device Lot Number: 11403590
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1