MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM CANNULATED VA LOCKING SCREW/75MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.675

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional narrative: (b)(4).Date of event: unknown.Additional product code : hrs, hwc, complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, the patient underwent for a removal surgery due to distal epiphysis fracture of the right femur.During the surgery, tried to remove all implanted materials but all implants have not been removed from the patient.The blocked cannulated va screw of 5.0 l 75 mm was positioned at an angle greater than fifteen degrees proximally.The surgery was completed successfully.There were no fragments are generated.There were no patient consequences.Concomitant devices reported: cortical screws (part# 214.834; lot# 47p9061; quantity: 2), cortical screws (part# 214.834; lot# l814671; quantity: 1), cortical screws (part# 214.842; lot# 76p1595; quantity: 1), cortical screws (part# 214.844; lot# l812151; quantity: 2), 5.0 cannulated va lck scrw/70 (part# 02.231.670; lot# l498011; quantity: 2), va-lcp condylar plate 4.5/5.0 (part# 02.124.407; lot# 48p0003; quantity: 1), cann-lockscr ¿5 l70 sst (part# 02.205.070; lot# 62p4598; quantity: 1).This complaint involves three (3) devices.This report is for (1) 5.0mm cannulated va locking screw/75mm.This report is 1 of 3 pc (b)(4).

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.Investigation summary: 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.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: device history lot: part#: 02.231.675, lot#: 64p8118, manufacturing site: mezzovico, release to warehouse date: 07 aug 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/75MM
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11520133
• MDR Text Key: 245338077
• Report Number: 8030965-2021-02135
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062901
• UDI-Public: (01)10886982062901
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.231.675
• Device Catalogue Number: 02.231.675
• Device Lot Number: 64P8118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Treatment: 4.5 VACRVD CONDY PL/14H/301/RT.; 5.0 CANNULATED VA LCK SCRW/75.; CANN-LOCKSCR Ø5 L70 SST.; CANN-LOCKSCR Ø5 L75 SST.; CORTSCR Ø4.5 SELF-TAP L34 SST.; CORTSCR Ø4.5 SELF-TAP L34 SST.; CORTSCR Ø4.5 SELF-TAP L42 SST.; CORTSCR Ø4.5 SELF-TAP L44 SST.; VA-LCP CONDYLAR PLATE 4.5/5.0.
• Patient Age: 34 YR