MAUDE Adverse Event Report: SYNTHES GMBH 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.008.066

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the implant was removed due to pseudo arthrosis and replaced by one with a larger diameter. Procedure was completed without any complication and no patient involvement. This report is for one (1) expert han ø10 le cann l180 tan light gr. This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is a j&j employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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 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: 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13725174
• Report Number: 8030965-2022-01505
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819869745
• UDI-Public: (01)07611819869745
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 04.008.066
• Device Lot Number: H830466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown
• Patient Age: 32 YR
• Patient Sex: No Answer Provided
• Patient Weight: 62 KG
• Patient Treatment(s): UNK - WASHERS.
• Patient Outcome(s): Required Intervention