MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1; WIRE,SURGICAL

Catalog Number 292.620S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.Additional device product code: lrn.State: (b)(6).¿ (510k): unknown; device is not distributed in the united states, but is similar to device marketed in the usa.Device history lot sterile part: part: 292.620s.Lot: 7l80430.Manufacturing site: (b)(4).Supplier.(b)(4).Release to warehouse date: 02.Feb.2021.Expiry date: 01.Feb.2031.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile part.Part: 292.620.Lot: 83p0762.Manufacturing site: (b)(4).Device history batch null device history review part: 292.620.Lot: 83p0762.Manufacturing site: (b)(4).Release to warehouse date: 18.Jan 2021.A manufacturing record evaluation was performed for the finished device 292.620 lot number 83p0762 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

It was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the distal tibial medial malleolus fracture with the guide wire in question.During the surgery, the guide wire broke, and the fragment was generated.When the surgeon checked the image intensifier after final fixation, he noticed that the guide wire had been broken and the fragment was left in the patient.The surgery was completed with the fragment remained because he thought that he had difficulty in removing the fragment.The surgeon commented that the technical error caused the breakage of the guide wire.No further information is available.This complaint involves one (1) device.This report is for one (1) guidewire ¿1.25 w/thread-tip w/trocar l1.This report is 1 of 1 for (b)(4).

• Brand Name: GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• MDR Report Key: 11851019
• MDR Text Key: 258292166
• Report Number: 8030965-2021-04040
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: 7L80430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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
• Patient Outcome(s): Required Intervention