MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø1 W/DOUB TIP L150 SST; WIRE, SURGICAL

Catalog Number 292.500.01

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

Patient Problem Inflammation (1932)

Event Date 02/05/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 292.500.01, lot: 31p0650, manufacturing site: (b)(4), release to warehouse date: 5.Dec2019.A manufacturing record evaluation was performed for the finished device 292.500.01 lot number 31p0650, and no non-conformances were identified.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: post-op inflammation.This case is from health authority.It was reported that the patient was operated under nerve block anesthesia due to the left little finger trauma.The incision was good after operation.At about the third week after operation, the middle segment of the left little finger suffered from erythema and inflammation, and the site where device was used had wound secretion of light yellow liquid.The patient was hospitalized again.Two days later, the middle segment of the left little finger was cut, debridement and internal fixation.Pterygium like exudation around the device was found.After operation, the wound dressing was changed, lornoxicam and sodium aescinate were used to reduce swelling and pain.After 25 days, the patient was discharged from the hospital, and the wound healed without erythema and inflammation.No additional information could be provided.This complaint involves one (1) devices k-wire ø1 w/doub tip l150 sst.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part: 292.500.01 lot: 31p0650 manufacturing site: balsthal release to warehouse date: 5.Dec2019 a manufacturing record evaluation was performed for the finished device 292.500.01 lot number 31p0650, and no non-conformances were identified.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.

• Brand Name: K-WIRE Ø1 W/DOUB TIP L150 SST
• Type of Device: WIRE, SURGICAL
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14087706
• MDR Text Key: 289105245
• Report Number: 8030965-2022-02382
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319851
• UDI-Public: (01)07611819319851
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.500.01
• Device Lot Number: 31P0650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male