MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM THREADED CERCLAGE POSITIONING PIN; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 298.803.01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states but is similar to device marketed in the usa.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2020, the patient underwent for reduction of periprosthetic fracture in the left femur.During the surgery it was noticed that there was no instrument box corresponding to the cable and tension system.The surgeon used alternate instruments used for the proposed fixation of the proximal femur plate.The surgeon reduces the fracture and tension of the system, then fix the cable system using institutional material.The procedure was completed successfully without delay.The patient outcome was unknown.Concomitant device reported: unknown proximal femur plate (part # unknown, lot # unknown, quantity unknown).This is report 03 of 03 of (b)(4).

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.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.Device history lot no combination could be found in jde or docusphere for part # 298.303.01 with lot # 16l9654, therefore a dhr review could not be performed at this time.If further information becomes available regarding the identifies for this part, then this dhr review will be revisited.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: 4.5MM THREADED CERCLAGE POSITIONING PIN
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9756630
• MDR Text Key: 190006744
• Report Number: 8030965-2020-01436
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819788503
• UDI-Public: (01)07611819788503
• Combination Product (y/n): N
• PMA/PMN Number: K992891
• 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: 01/28/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 298.803.01
• Device Lot Number: 16L9654
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/10/2020
• Patient Sequence Number: 1
• Treatment: CERCL-CABLE W/CRIMP Ø1 SST; CORTSCR Ø4.5 SELF-TAP L22 SST; CORTSCR Ø4.5 SELF-TAP L36 SST; CORTSCR Ø4.5 SELF-TAP L42 SST; LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3; LCP PROXFEM HOOKPL 4.5/5 SHAFT 14HO L349; LOCKSCR Ø5 SELF-TAP L46 SST; UNK - PLATES; UNK - TENSIONING INSTRUMENTS
• Patient Outcome(s): Required Intervention