MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM SS 2.7X 14MMCORTEX; BONE FIXATION PLATE

Model Number	LO-PRO SCRW TM SS 2.7X 14MMCORTEX
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.One unpackaged ar-8827-14 low profile screw¿, 2.7 x 14 mm, cortex, batch 1074240, was returned for investigation.The returned screw was visually inspected and it was noted that no visual issues.Upon functional testing with the returned mating part ar-2652cl, the low-profile screw fit was too loose on the locking holes.The screw is too small.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.

• Brand Name: LO-PRO SCRW TM SS 2.7X 14MMCORTEX
• Common Device Name: BONE FIXATION 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: 17326400
• Report Number: 1220246-2023-07162
• Device Sequence Number: 14830248
• Product Code: HRS
• UDI-Device Identifier: 00888867046757
• UDI-Public: 00888867046757
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141478
• 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): 11/02/2023

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 2.7X 14MMCORTEX
• Device Catalogue Number: AR-8827-14
• Device Lot Number: 1074240
• 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: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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