MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM TI ELASTIC NAIL 440MM; PIN,FIXATION,SMOOTH

Catalog Number 475.925

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).Additional narrative: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.Investigation summary: 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.Part number: 475.925.Lot number: 17p8979.Part manufacture date: 03-oct 03, 2019.Manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ten 2.5 l440 tan pink product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review 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 synthes reports an event in (b)(6) as follows: it was reported that on march 13, 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) 2.5mm ti elastic nail 440mm this report is 1 of 2 (b)(4).

• Brand Name: 2.5MM TI ELASTIC NAIL 440MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11724629
• MDR Text Key: 247284818
• Report Number: 8030965-2021-03256
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819093010
• UDI-Public: (01)07611819093010
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971783
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 475.925
• Device Lot Number: 17P8979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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: END CAP F/TEN Ø1.5-2.5 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR