MAUDE Adverse Event Report: SYNTHES GMBH LCKNG SCR 5/40/HDLESS/XL25/S; SCREW, FIXATION, BONE

Catalog Number	04.045.340S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, the patient underwent orif surgery for tibia with the products in question.The surgery was completed successfully with no surgical delay.After the surgery, distal screw backout and screw advancement were confirmed.The revision surgery occurred on an unknown date.The low-profile screws were used in all necessary areas.The screws and nail were removed and replaced with intramedullary nails from another company.Procedure completed successfully.Patient is stable.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: b5.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device history lot: a dhr review could not be performed for this pi.This is an invalid lot number.Please confirm / correct the lot number and resubmit.Device history review: a dhr review could not be performed for this pi.This is an invalid lot number.Please confirm / correct the lot number and resubmit.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that the patient has anorexia.The low-profile screws were used in all necessary areas.The screws and nail were removed and replaced with intramedullary nails from another company.No other medical intervention was required.

• Brand Name: LCKNG SCR 5/40/HDLESS/XL25/S
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21343162
• Report Number: 8030965-2025-01425
• Device Sequence Number: 8959594
• Product Code: HWC
• UDI-Device Identifier: 10886982294982
• UDI-Public: (01)10886982294982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 04.045.340S
• Device Lot Number: 2021P4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown