MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw has loosened in the clavicle plate.No further information received.27-jun-2023 update dw: further information were provided that the following devices became loose post op.Ar-2652cl batch: 5262102; ar-8835l-14 batch: 15040867; ar-8835-14 batch: 10694746; 2x ar-8835-16 batch: 1072011; 3x ar-8835-18 batch: 10591283; ar-8827-14 batch: 1074240.As the reported devices are available for return a revision surgery had to be performed but no further information were provided when the revision surgery was performed.
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Additional Manufacturer Narrative
The complaint allegation was confirmed.Only was screw was received for this size.One unpackaged ar-8835-16 low profile screw¿, ss, 3.5 x 16 mm, cortical, batch unk, was returned for investigation.The returned screw was visually inspected, and it was noted no visual defects.Upon functional testing with the returned mating part ar-2652cl, the low-profile screw fit loose on the locking holes.However, the screw has the correct size per drawing c18816 at revision 1.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is a user error.Per dfu-0125 at rev.2.G.1.Surgeons must apply their professional judgment when determining the appropriate screw size based on the specific indication, preferred surgical technique, and patient history.2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.3.Use the appropriately sized drill bit for the screw.4.Damage to the driver or screw may result from failure to seat the driver fully into the screw or to align the driver properly with the screw.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17326428
• Report Number: 1220246-2023-07164
• Device Sequence Number: 12146657
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Device Catalogue Number: AR-8835-16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown