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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM-STERILE PIN,FIXATION,SMOOTH

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SYNTHES SELZACH 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM-STERILE PIN,FIXATION,SMOOTH Back to Search Results
Catalog Number 02.226.001S
Device Problems Break; Material Fragmentation
Event Date 03/08/2017
Event Type  Injury  
Manufacturer Narrative

Additional narrative: patient identifier and weight are not available for reporting. Additional code: hwc. Two (2) possible lot numbers reported. Lot number 9902157, manufacture date april 8, 2016, expiration date march 1, 2026. (b)(4). Lot number l039203, manufacture date june 27, 2016, expiration date june 1, 2026. (b)(4). Device was not implanted or explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant device, part 03. 226. 039, partial lot number l225x4. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. Article 02. 226. 001s with lot 9902157 please note, this dhr review is for sterilization procedure only manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 08. Apr. 2016 expiry date: 01. Mar. 2026. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Non-sterile 02. 226. 001 / 9879022. Manufacturing location: (b)(4), manufacturing date:11. Mar. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Article 02. 226. 001s with lot l039203. Please note, this dhr review is for sterilization procedure only, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 27. Jun. 2016 expiry date: 01. Jun. 2026. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Non-sterile 02. 226. 001 / 9965823. Manufacturing location: (b)(4), manufacturing date: 24. May. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product 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 europe reports an event in (b)(6) as follows: it is reported during a calcaneal fracture procedure on (b)(6) 2017; while surgeon was drilling a guide wire broke. The broken fragment remains embedded in the patient. Surgeon used another guide wire to insert a screw and used a jacobs chuck when inserting the guide wire. No surgical delay or need for other medical intervention was required. Patient status reported as good. Concomitant devices reported: jacobs chuck (part number unknown, lot number unknown, quantity 1), drill bit (part 03. 226. 039, lot number unknown, partial lot l225x4, quantity 1), screw (part number unknown, lot number unknown, quantity 1). This report is for one (1) guide wire. This is report 1 of 1 for (b)(4).

 
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Brand Name1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM-STERILE
Type of DevicePIN,FIXATION,SMOOTH
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key6473022
Report Number3000270450-2017-10122
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.226.001S
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/07/2017 Patient Sequence Number: 1
Treatment
DRILL BIT (PART 03.226.039, LOT UNKNOWN, QTY 1)
JACOBS CHUCK (PART AND LOT UNKNOWN, QTY 1)
SCREW (PART AND LOT UNKNOWN, QTY 1)
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