MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.244S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 manufacturing location: (b)(4).Manufacturing date: 20-oct-2017.Expiration date: 01-oct-2027.Part number: 04.037.244s, 12mm/130 deg ti cann tfna 235mm / right- sterile.Lot number: h478723 (sterile).Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿tfna blade missed the nail¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent the surgery with the fns implants.On an unknown date, the surgeon confirmed that non-union occurred.The patient will undergo the revision surgery to remove the implants.It is non-union because the bone quality was not good, and the blood flow stagnated at the time of injury.The implant was removed successfully on (b)(6) 2020.No further information is available.This complaint involves four (4) devices.This report is for (1) unk - screws: locking.This is report 4 of 4 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10810152
• MDR Text Key: 217442283
• Report Number: 8030965-2020-08777
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651241
• UDI-Public: (01)07611819651241
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.244S
• Device Lot Number: H478723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention