MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM TI LOCKING BOLT 32MM; PIN,FIXATION,SMOOTH

Catalog Number 459.32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: jdw, jds, jdn, and hsb.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes employee.Part: 459.320, lot: 5945184, manufacturing site: (b)(4), release to warehouse date: february 14, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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.(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 that on an unknown date, that the patient experienced a post-op fracture.The patient suffered from fracture on his right thigh on (b)(6) 2020.Previously on (b)(6) 2019, the patient underwent the surgery of reduction of right subtrochanteric fracture and internal fixation with intramedullary nail.The patient underwent the surgery of right femoral incision and intramedullary nail removal, and then intramedullary nail fixation of right femoral fracture on (b)(6) 2020.Concomitant device reported: tfn nail (part number unknown, lot unknown, quantity 1), tfn helical blade (part number unknown, lot unknown, quantity 1), tfn end cap (part number unknown, lot unknown, quantity 1), locking screw (part number unknown, lot unknown, quantity unknown).This report involves one (1) 4.9mm ti locking bolt 32mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.9MM TI LOCKING BOLT 32MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; 1020 WIEN; SZ 1020 WIEN
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10250444
• MDR Text Key: 198139561
• Report Number: 8030965-2020-04737
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819043107
• UDI-Public: (01)07611819043107
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2020

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: 459.32
• Device Lot Number: 5945184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFN; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE; UNK - NAILS: TFN; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR