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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI LCP RADIAL HEAD NECK PLATE 2 HOLES PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM TI LCP RADIAL HEAD NECK PLATE 2 HOLES PLATE, FIXATION, BONE Back to Search Results
Catalog Number 441.690S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was conducted: part: 441. 690s, lot: 8l16481, manufacturing site: (b)(4), supplier: früh verpackungstechnik ag, release to warehouse date: 20 may 2021, expiration date: 01 may 2031. A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. Non-sterile. Part: 441. 690. Lot: 92p0603. 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 intra-articular fracture of proximal radius with the plate and the locking screw. When the surgeon inserted the locking screw into the left screw hole in the distal second row, which was one of five screw holes in the epiphysis of the plate, and fixed it, the locking screw penetrated the plate and entered the bone with the plate unlocked. The surgeon tried to remove it, but the locking screw had entered under the plate and it was difficult to remove it. Because the surgery time had already exceeded two (2) hours, the doctor left the locking screw inside the bone and the surgery was completed successfully with fifteen (15) minutes surgical delay. No further information is available. This report is for one (1) 2. 4mm ti lcp radial head neck plate 2 holes. This is report 1 of 2 for complaint (b)(4).
 
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Brand Name2.4MM TI LCP RADIAL HEAD NECK PLATE 2 HOLES
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12580064
MDR Text Key274974934
Report Number8030965-2021-08393
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number441.690S
Device Lot Number8L16481
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 Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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