MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE 1 W/DOUB TIP L150 TAV; NAIL, FIXATION, BONE

Catalog Number 492.5

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Fluid Discharge (2686)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.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 history review: part: 492.500, lot: 36p9279, manufacturing site: (b)(4), release to warehouse date: feb 10, 2020.A manufacturing record evaluation was performed for the finished device lot number 36p9279, and no non-conformances were identified.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) 2020 the patient suffered from erythema, inflammation and wound secretion after using the product in the surgery of debridement and exploration of left little finger, reduction and internal fixation of phalanx fracture, repair of blood vessel, nerve and tendon of little finger on (b)(6) 2020.It was considered that the patient had an allergy to kirschner wire and the wire was removed on (b)(6) 2020.The patient condition is reported to be better.This case is from a health authority.This report is for one (1) k-wire 1 w/doub tip l150 tav.This is report 1 of 1 for (b)(4).

• Brand Name: K-WIRE 1 W/DOUB TIP L150 TAV
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10937520
• MDR Text Key: 219347626
• Report Number: 8030965-2020-09340
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819066175
• UDI-Public: (01)07611819066175
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 492.5
• Device Lot Number: 36P9279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR