MAUDE Adverse Event Report: SYNTHES GMBH ARTICULATED TENSION DV GAUGE-SPAN 20; INSTRUMENT, COMPRESSION

Catalog Number	321.12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in (b)(6) 2024, a prophylactic tfna was inserted to the patient¿s left hip along with a cement spacer where there was a cancer tumor near the intertrochanteric region.Months later as expected, a fracture occurred and continued to a non-union.On (b)(6) 2025, the tfna was removed including the lag screw, the nail and both interlocking distal screws.The 5.0 distal interlocking screws were broken, and both were retrieved, except one piece of the most distal screw.The surgeon was not concerned and left it in the femur.The revision then continued by removing the cement spacer followed by using the reamer irrigator aspirator to collect bone graft.Then a 95° blade plate 80 mm blade was inserted, while reducing with the articulating tension device item number 321.12 the small pins sheared, and the articulating tension device broke.All parts were removed with ease.Then a new articulating tension device was introduced.The rest of the case was completed successfully with no surgical delays and no patient harm.There was no patient consequences.There was no surgical delay.All available information has been disclosed for reporting.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D4: udi: as the lot number for the device involved in the event was not provided, 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: corrected: e1 (facility name).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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial report, a follow-up report 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: h3, h6: service and repair evaluation: the customer reported that it was reported that in (b)(6) 2024, a prophylactic tfna was inserted to the patient¿s left hip along with a cement spacer where there was a cancer tumor near the intertrochanteric region.Months later as expected, a fracture occurred and continued to a non-union.On (b)(6) 2025, the tfna was removed including the lag screw, the nail and both interlocking distal screws.The 5.0 distal interlocking screws were broken, and both were retrieved, except one piece of the most distal screw.The surgeon was not concerned and left it in the femur.The revision then continued by removing the cement spacer followed by using the reamer irrigator aspirator to collect bone graft.Then a 95° blade plate 80 mm blade was inserted, while reducing with the articulating tension device item number 321.12 the small pins sheared, and the articulating tension device broke.All parts were removed with ease.Then a new articulating tension device was introduced.The rest of the case was completed successfully with no surgical delays and no patient harm.Sales rep do not have the numbers for the broken 5.0 interlocking screws.There was no patient consequences.The repair technician reported that broken tip, dissembled device, missing lot number, cosmetics tested failed.The cause of the issue is faulty parts.The item was repaired per the inspection sheet, passed synthes final inspection on 27-feb -2025 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in mds&r.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history review (dhr): the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICULATED TENSION DV GAUGE-SPAN 20
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21439040
• Report Number: 8030965-2025-01828
• Device Sequence Number: 19920552
• Product Code: HWN
• UDI-Device Identifier: 10886982190369
• UDI-Public: (01)10886982190369
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: 321.12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 03/21/2025; 03/25/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/17/2025; 03/24/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male