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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM PLATE, FIXATION, BONE

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SYNTHES GMBH 2.0MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 401.882S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. 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 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) 2021, the patient underwent the open reduction internal fixation surgery for the distal radius and ulna fracture with the drill bit and the locking screw in question. During the surgery, the drill bit broke when it was removed from a sleeve. Also, the locking screw was not locked to a plate and another screw was used. The surgery was completed successfully with 30minutes delay. Concomitant devices reported: unknown sleeve (part# unknown, lot# unknown, quantity 1), unknown distal radius plate (part# unknown, lot# unknown, quantity 1). This report is for one (1) 2. 0mm ti locking scr slf-tpng with stardrive recess 12mm. This is report 2 of 2 for complaint (b)(4).

 
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Brand Name2.0MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM
Type of DevicePLATE, FIXATION, BONE
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 Key12300602
MDR Text Key265806474
Report Number8030965-2021-06545
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK063049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number401.882S
Device LOT Number7L95274
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2021
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/10/2021 Patient Sequence Number: 1
Treatment
DRILL BIT Ø1.1 L45/33 2FLUTE; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - PLATES: DISTAL RADIUS
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