MAUDE Adverse Event Report: SYNTHES GMBH TITANIUM END CAP FOR TITANIUM ELASTIC NAILS 1.5-2.5MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 475.905

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

Patient Problems Erythema (1840); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing 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 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 (b)(6), the patient suffered from erythema and inflammation on the skin near the device which was used for treating right fibula fracture in an unknown surgery on (b)(6) 2021.Immediate use of anti-swelling medication, continued observation and treatment were given to the patient.No additional information could be provided.This complaint involves two (2) devices.This report is for (1) titanium end cap for titanium elastic nails ø1.5-2.5mm.This report is 2 of 2 (b)(4).

• Brand Name: TITANIUM END CAP FOR TITANIUM ELASTIC NAILS 1.5-2.5MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11724631
• MDR Text Key: 247303492
• Report Number: 8030965-2021-03258
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819329126
• UDI-Public: (01)07611819329126
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 475.905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TEN Ø2.5 L440 TAN PINK
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR