MAUDE Adverse Event Report: SYNTHES GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

Catalog Number 292.620S

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Sterile - part.Part: 292.620s.Lot: 7l27698.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 14.Sept.2020.Expiry date: 01.Sept.2030.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non - sterile - part.Part: 292.620.Lot: 64p4020.Manufacturing site: (b)(4).Release to warehouse date: 29.Aug 2020.A manufacturing record evaluation was performed for the finished device lot number 64p4020, 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent an open reduction internal fixation surgery for an ankle fracture.During the surgery, after the guide wire insertion, when the surgeon drilled with the drill bit, the drill bit interfered with the guide wire.The surgeon stopped drilling and pulled out the guide wire, but it had been broken.The tip of the guide wire remained in the bone.The surgeon continued the surgery without removing the fragment and the surgery was completed successfully with less than thirty (30) minute delay.The fragment removal is not scheduled.The surgeon commented that there was no problem for the patient because the guide wire remained in the bone not in the joint.This event was not caused by the product.The surgeon used a bent drill bit which caused this event.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11126380
• MDR Text Key: 227502626
• Report Number: 8030965-2021-00108
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: 7L27698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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